Baxa Corp., Sub. of Cook Group, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Baxa Corp., Sub. of Cook Group, Inc.” (first 1978, latest 1991), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | 7 | 7 |
| KPE | Container, I.V. | 5 | 5 |
| FMF | Syringe, Piston | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| KYX | Dispenser, Liquid Medication | 1 | 1 |
| MEA | Pump, Infusion, Pca | 1 | 1 |
Review panels
- General Hospital (16)
Most recent Baxa Corp., Sub. of Cook Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910257 | BAXA PCA INFUSOR | MEA | 1991-11-07 | 289 |
| K903159 | VALVE CONTROLLER FOR MICROMACRO COMPOUNDER | LHI | 1990-11-07 | 112 |
| K904225 | KWIKMIX | LHI | 1990-11-05 | 53 |
| K900585 | TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP | LHI | 1990-04-18 | 70 |
| K873875 | BAXA EXACTA-MED PHARMACY PUMP | FRN | 1987-11-24 | 63 |
| K872743 | BAXA TUBING SETS (FOR PHARMACY PUMP) | FMF | 1987-10-09 | 88 |
| K844904 | CYTOSAFE NEEDLE | LHI | 1985-02-22 | 67 |
| K832347 | TWOFER NEEDLE | LHI | 1983-09-12 | 56 |
| K832332 | VENTED I.V. TRANSFER NEEDLE | LHI | 1983-09-12 | 56 |
| K832312 | I.V. TRANSFER NEEDLE | LHI | 1983-09-12 | 60 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Baxa Corp., Sub. of Cook Group, Inc..
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 Baxa Corp., Sub. of Cook Group, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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.
- Baxa Corp. (8 510(k)s)
- Baxa Infusion Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Baxa Corp., Sub. of Cook Group, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Baxa Corp., Sub. of Cook Group, Inc.” (first 1978, latest 1991), across 6 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 Baxa Corp., Sub. of Cook Group, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Baxa Corp., Sub. of Cook Group, Inc. is 58 days.
Which FDA product codes appear under Baxa Corp., Sub. of Cook Group, Inc.?
The most frequent FDA product codes under this applicant name are LHI (Set, I.V. Fluid Transfer, 7); KPE (Container, I.V., 5); FMF (Syringe, Piston, 1).
Next steps
- See all 16 Baxa Corp., Sub. of Cook Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LHI, Baxa Corp., Sub. of Cook Group, Inc.'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.