Precision Biologic: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Precision Biologic” (first 1999, latest 2025), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 106 days. Since 2017 the median was 272 days, against 184 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 90 |
| 2020 | 2 | 272 |
| 2021 | 0 | — |
| 2022 | 1 | 367 |
| 2023 | 1 | 359 |
| 2024 | 0 | — |
| 2025 | 1 | 108 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Precision Biologic took a median 272 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 184 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 7 | 7 |
| GJT | Plasma, Coagulation Factor Deficient | 3 | 3 |
| GIR | Reagent, Russel Viper Venom | 2 | 2 |
| GFO | Activated Partial Thromboplastin | 1 | 1 |
| GGC | Control, Plasma, Abnormal | 1 | 1 |
| GGW | Test, Time, Partial Thromboplastin | 1 | 1 |
| GIZ | Plasma, Control, Normal | 1 | 1 |
| JBQ | Antithrombin Iii Quantitation | 1 | 1 |
Review panels
- Hematology (17)
Most recent Precision Biologic 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251440 | CRYOcheck Chromogenic Factor VIII | GGP | 2025-08-25 | 108 |
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | GJT | 2023-09-13 | 359 |
| K214002 | CRYOcheck Chromogenic Factor IX | GGP | 2022-12-23 | 367 |
| K193556 | Cryocheck Hex LA | GFO | 2020-10-23 | 305 |
| K193204 | Cryocheck Chromogenic Factor VIII | GGP | 2020-07-17 | 240 |
| K183440 | CRYOcheck FVIII Inhibitor Kit | GGP | 2019-03-12 | 90 |
| K060284 | CRYOCHECK CLOT APCR | GGW | 2006-05-10 | 96 |
| K043571 | CRYOCHECK CLOT S | GGP | 2005-03-18 | 81 |
| K040987 | CRYOCHECK CLOT C | GGP | 2004-06-18 | 64 |
| K032804 | CRYOCHECK WEAK LUPUS POSITIVE CONTROL | GGC | 2003-11-03 | 55 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Precision Biologic.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Precision Biologic (a text match, not an official crosswalk):
- J7197 — Antithrombin iii (human), per i.u. (via JBQ)
- J7213 — Injection, coagulation factor ix (recombinant), ixinity, 1 i.u. (via GJT)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Precision Medical, Inc. (30 510(k)s)
- Precision Dynamics Corp. (26 510(k)s)
- Precision Spine, Inc. (26 510(k)s)
- Precision Biologicals, Inc. (20 510(k)s)
- Precision Med Products, Ltd. (16 510(k)s)
- Precision Acoustics Ind., Inc. (9 510(k)s)
- Precision Cap Systems (7 510(k)s)
- Precision Vascular Systems, Inc. (7 510(k)s)
- Precision Instruments, Inc. (4 510(k)s)
- Precision Laser Products, Inc. (4 510(k)s)
- Precision Medical Instruments, Inc. (4 510(k)s)
- Precision Therapy Intl., Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Precision Biologic?
FDA lists 17 510(k) clearances under the applicant name “Precision Biologic” (first 1999, latest 2025), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Precision Biologic?
The median time from FDA receipt to decision across 510(k)s cleared under the name Precision Biologic is 106 days. Since 2017: 272 days, versus 184 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Precision Biologic?
The most frequent FDA product codes under this applicant name are GGP (Test, Qualitative And Quantitative Factor Deficiency, 7); GJT (Plasma, Coagulation Factor Deficient, 3); GIR (Reagent, Russel Viper Venom, 2).
Next steps
- See all 17 Precision Biologic clearances with predicates and recalls
- Run predicate analysis for product code GGP, Precision Biologic's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.