Chrysalis Intelligence · Product Codes · JWY

JWY · Unclassified

39 clearances · 7 unique sponsors

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Device class
—
Regulation —
Total clearances
39
2020-01-08 → 2026-04-21
Last 12 months
6
Unique sponsors
7
Classification details
Medical specialty
—
Review panel
—
Regulation number
—
Implant
—
Life-sustain / support
—
GMP exempt
—
Third-party review
—
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Thermo Fisher Scientific 24 3 2025-09-25
Liofilchem s.r.l. 7 2 2026-04-17
Biomerieux S.A. 2 0 2025-04-30
Biomérieux 2 0 2025-06-12
bioMérieux SA 2 1 2026-04-21
Beckman Coulter, Inc. 1 0 2021-05-18
Liofilchem S. R. 1. 1 0 2020-04-06
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
87181 CPT — High CPT code for antimicrobial susceptibility testing, manual methods
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-21 K260447 bioMérieux SA ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
2026-04-17 K260696 Liofilchem s.r.l. MTS Gepotidacin 0.016-256 µg/mL
2025-10-02 K252114 Liofilchem s.r.l. MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
2025-09-25 K252062 Thermo Fisher Scientific The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
2025-09-05 K250575 Thermo Fisher Scientific The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
2025-08-28 K252014 Thermo Fisher Scientific The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
2025-08-20 K251580 Liofilchem s.r.l. MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
2025-06-30 K250990 Thermo Fisher Scientific The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL
2025-06-20 K242843 Thermo Fisher Scientific The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.
2025-06-12 K250856 Biomérieux ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)
2025-05-22 K242659 Thermo Fisher Scientific The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL
2025-04-30 K250274 Biomerieux S.A. ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
2025-04-15 K242658 Thermo Fisher Scientific The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL
2025-02-10 K243201 Thermo Fisher Scientific The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL
2025-02-10 K242905 Thermo Fisher Scientific The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL
2025-01-30 K243202 Liofilchem s.r.l. MTS Ceftobiprole 0.002-32 µg/mL
2024-12-19 K243169 Thermo Fisher Scientific The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL
2024-12-05 K242653 Thermo Fisher Scientific The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL
2024-11-26 K242657 Thermo Fisher Scientific The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL
2024-10-09 K242021 Thermo Fisher Scientific The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml.
2024-10-01 K241967 Thermo Fisher Scientific The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml.
2024-05-16 K240445 Thermo Fisher Scientific The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.
2023-10-31 K232310 Thermo Fisher Scientific Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml
2023-10-05 K232395 Biomérieux ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
2023-08-30 K231988 Thermo Fisher Scientific Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence