Device class
—
Regulation —
Total clearances
3
2024-07-12 → 2026-06-18
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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.
| Code | Type | Description | Confidence | Rationale |
| 88079 |
CPT
|
— |
High
|
Biological indicator for sterilization validation, standard code for monitoring sterilization efficacy |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-06-18 |
K251559 |
True Indicating, LLC
|
InstaTRU Instant Biological Indicator for Steam (IBI-05) |
| 2026-04-22 |
K252306 |
Steritec Products
|
Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100) |
| 2024-07-12 |
DEN220042 |
Terragene S.A.
|
Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) |