Pacific Hemostasis: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Pacific Hemostasis” (first 1978, latest 2000), across 17 product codes in 2 review panels. Median 510(k) review time under this name: 42 days. 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 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | 5 | 5 |
| GJS | Test, Time, Prothrombin | 5 | 5 |
| GGC | Control, Plasma, Abnormal | 2 | 2 |
| GHM | Test, Sickle Cell | 2 | 2 |
| GJT | Plasma, Coagulation Factor Deficient | 2 | 2 |
| KQG | Instrument, Coagulation | 2 | 2 |
| DHX | System, Test, Carcinoembryonic Antigen | 1 | 1 |
| GFO | Activated Partial Thromboplastin | 1 | 1 |
| GGW | Test, Time, Partial Thromboplastin | 1 | 1 |
| GHH | Fibrin Split Products | 1 | 1 |
Plus 7 more product codes.
Review panels
- Hematology (28)
- Immunology (1)
Most recent Pacific Hemostasis 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000679 | THROMBOSTRATE CONTROL PLASMAS | GGN | 2000-03-24 | 24 |
| K994100 | PACIFIC HEMOSTASIS THROMBOPLASTIN D | GJS | 2000-02-18 | 77 |
| K992130 | PACIFIC HEMOSTASIS THROMBOSCREEN 400C | KQG | 1999-09-03 | 72 |
| K992279 | HEPARIN CONTROL PLASMA LEVEL 2 | GGN | 1999-08-26 | 50 |
| K992278 | HEPARIN CONTROL PLASMA LEVEL 1 | GGN | 1999-08-26 | 50 |
| K991321 | PACIFIC HEMOSTASIS THROMBOSCREEN 200 | KQG | 1999-06-21 | 63 |
| K990046 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA | GJT | 1999-02-17 | 41 |
| K984131 | COAGULATION CONTROL LEVEL 3 (ABNORMAL) | GGC | 1998-12-01 | 13 |
| K984130 | COAGULATION CONTROL LEVEL 2 (ABNORMAL) | GGC | 1998-12-01 | 13 |
| K984129 | COAGULATION CONTROL LEVEL 1 (NORMAL) | GIZ | 1998-12-01 | 13 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pacific Hemostasis.
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 Pacific Hemostasis (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.
- Pacific Biotech, Inc. (29 510(k)s)
- Pacific Dental Corp. (22 510(k)s)
- Pacific Device, Inc. (5 510(k)s)
- Pacific Union Dental, Inc. (5 510(k)s)
- Pacific Materials and Interfaces (3 510(k)s)
- Pacific Andrology, Inc. (2 510(k)s)
- Pacific Consolidated Industries (2 510(k)s)
- Pacific Consolidated Industries, LLC (2 510(k)s)
- Pacific Consolidated Industries Llp (2 510(k)s)
- Pacific Delta Medical Supply (2 510(k)s)
- Pacific Implant, Inc. (2 510(k)s)
- Pacific Medico Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pacific Hemostasis?
FDA lists 29 510(k) clearances under the applicant name “Pacific Hemostasis” (first 1978, latest 2000), across 17 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pacific Hemostasis?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pacific Hemostasis is 42 days.
Which FDA product codes appear under Pacific Hemostasis?
The most frequent FDA product codes under this applicant name are GGN (Plasma, Coagulation Control, 5); GJS (Test, Time, Prothrombin, 5); GGC (Control, Plasma, Abnormal, 2).
Next steps
- See all 29 Pacific Hemostasis clearances with predicates and recalls
- Run predicate analysis for product code GGN, Pacific Hemostasis'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.