Baxa Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Baxa Corp.” (first 1994, latest 2010), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 180 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 | 3 | 3 |
| FRN | Pump, Infusion | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| ODI | Administration Set Docking Station | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Baxa Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090917 | SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | LHI | 2010-02-19 | 324 |
| K070163 | SWABBABLE CAP, MODEL 60205 | ODI | 2007-08-03 | 198 |
| K062909 | REPEATER PUMP II TUBE SETS | FPA | 2007-03-09 | 163 |
| K022523 | RAPID-FILL TUBESET, MODEL 90005 | LHI | 2002-08-12 | 13 |
| K002705 | EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 | LHI | 2001-03-28 | 210 |
| K983321 | MICROFUSE DUAL RATE INFUSER | FRN | 1998-10-06 | 14 |
| K951871 | PISTON SYRINGE | FMF | 1995-06-21 | 61 |
| K933506 | SYRINGE INFUSER | FRN | 1994-02-25 | 220 |
Recalls
40 product recalls in 15 recall events; 0 initiated in the last five years. Most recent: 2013-08-22.
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. (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., Sub. of Cook Group, Inc. (16 510(k)s)
- Baxa Infusion Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Baxa Corp.?
FDA lists 8 510(k) clearances under the applicant name “Baxa Corp.” (first 1994, latest 2010), across 5 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.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Baxa Corp. is 180 days.
Which FDA product codes appear under Baxa Corp.?
The most frequent FDA product codes under this applicant name are LHI (Set, I.V. Fluid Transfer, 3); FRN (Pump, Infusion, 2); FMF (Syringe, Piston, 1).
Next steps
- See all 8 Baxa Corp. clearances with predicates and recalls
- Run predicate analysis for product code LHI, Baxa Corp.'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.