Chrysalis Intelligence · Product Codes · FRC

FRC · Indicator, Biological Sterilization Process

General Hospital · 41 clearances · 9 unique sponsors

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Device class
Class II
Regulation 880.2800
Total clearances
41
2020-01-23 → 2026-04-08
Last 12 months
2
Unique sponsors
9
Classification details
Medical specialty
General Hospital
Review panel
HO
Regulation number
880.2800
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
3M Company 15 0 2025-01-28
STERIS Corporation 13 2 2026-04-08
Terragene 4 0 2025-08-04
Andersen Sterilizers, Inc. 3 0 2022-04-12
Plasmapp Co,., Ltd. 2 0 2023-05-09
3M Complany 1 0 2020-06-01
Advanced Sterilization Products (Asp) 1 0 2020-01-23
True Indicating, LLC 1 0 2020-12-28
Tso3 Inc., Now A Part of Stryker 1 0 2021-03-24
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
A4650 HCPCS Implantable radiation dosimeter, each ✓ CMS-verified description High Standard HCPCS code for sterilization indicators and biological monitoring devices
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-08 K260766 STERIS Corporation Celerity 5 HP Biological Indicator (LCB052)
2025-09-24 K252680 STERIS Corporation Celerity™ 20 HP Biological Indicator
2025-08-04 K251122 Terragene Terragene® Bionova® BT20 Biological Indicator
2025-06-06 K251452 Steris Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
2025-02-06 K250061 STERIS Corporation Celerity Incubator
2025-02-06 K250044 STERIS Corporation Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
2025-01-28 K243501 3M Company 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M
2024-12-12 K242453 Terragene S.A. Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)
2024-11-25 K242538 3M Company 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M
2024-10-18 K241959 3M Company 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)
2024-09-18 K231383 Terragene S.A. Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
2024-09-12 K241710 3M Company 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M
2024-06-27 K241542 3M Company 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)
2024-06-27 K240717 3M Company 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
2024-03-15 K233814 3M Company 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)
2023-12-15 K233681 STERIS Corporation ConFirm 20 Minute Incubator
2023-08-07 K231490 STERIS Corporation Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator
2023-06-15 K223717 STERIS Corporation Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack
2023-06-15 K223715 STERIS Corporation Celerity Incubator
2023-05-09 K223023 Plasmapp Co,., Ltd. Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
2023-02-28 K221641 Terragene S.A. Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)
2022-07-21 K213881 STERIS Corporation Celerity Incubator
2022-06-28 K211705 3M Company 3M Attest Rapid Readout Biological Indicator, 1295
2022-04-12 K213296 Andersen Sterilizers, Inc. Anprolene SteriTest RRBI
2022-04-06 K213809 3M Company 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence