Baxter Healthcare Corp: FDA filings under this applicant name

FDA lists 568 510(k) clearances under the applicant name “Baxter Healthcare Corp” (first 1977, latest 2025), plus 5 PMA and 1 De Novo decisions, across 193 product codes in 17 review panels. Median 510(k) review time under this name: 85 days. Since 2017 the median was 129 days, against 143 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.

Caduvo groups this applicant name under Baxter, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Baxter Healthcare Corp took a median 129 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 143 days.

Top product codes

Plus 183 more product codes.

Review panels

• General Hospital (223)
• Gastroenterology and Urology (100)
• Cardiovascular (65)
• Clinical Chemistry (53)
• General and Plastic Surgery (23)
• Microbiology (18)
• Orthopedic (18)
• Anesthesiology (16)
• Hematology (16)
• Obstetrics and Gynecology (16)
• Clinical Toxicology (7)
• Neurology (6)
• Physical Medicine (5)
• Dental (3)
• Pathology (3)
• Immunology (1)
• Radiology (1)

Most recent Baxter Healthcare Corp 510(k) clearances

558 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

752 product recalls in 307 recall events; 276 initiated in the last five years. Most recent: 2026-08-18.

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.

Device clinical trials

An industry sponsor named Baxter Healthcare Corp is the lead sponsor of 24 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:

• NCT07256951: Gen 2 Battrode Wear Study (Recruiting, started 2025-11-12)
• NCT07158333: Mobile Cardiac Telemetry (MCT) Study (Completed, started 2025-08-05)
• NCT05996809: PMCF Study for COSEAL® in Gynecologic Surgery (Completed, started 2024-06-03)
• NCT06056011: Timmy3 Module Clinical Accuracy ISO 80601-2-56:2017 + A1 2018 (Completed, started 2024-02-19)
• NCT05811585: PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery (Completed, started 2023-06-26)

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Baxter Healthcare Corp (a text match, not an official crosswalk):

• A4220 — Refill kit for implantable infusion pump (via FRN)
• J7197 — Antithrombin iii (human), per i.u. (via JBQ)
• G0008 — Administration of influenza virus vaccine (via GNW)
• E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
• 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.

• Baxter Diagnostics, Inc. (72 510(k)s)
• Baxter Edwards (11 510(k)s)
• Baxter Bentley Laboratories, Inc. (3 510(k)s)
• Baxter Healthcare Corportation (3 510(k)s)
• Baxter Healthcare Corporation - Renal Division (2 510(k)s)
• Baxter Corp. (1 510(k)s)
• Baxter Centre For Medical Research (1 510(k)s)
• Baxter Healthcare Corp., Bioscience (1 510(k)s)
• Baxter Healthcare Corp/ Excel Medical (1 510(k)s)
• Baxter Healthcare Corproration (1 510(k)s)
• Baxter Interwoven Offsite (1 510(k)s)
• Baxter Bio Science (0 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Baxter Healthcare Corp?

FDA lists 568 510(k) clearances under the applicant name “Baxter Healthcare Corp” (first 1977, latest 2025), plus 5 PMA and 1 De Novo decisions, across 193 product codes in 17 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 Baxter Healthcare Corp?

The median time from FDA receipt to decision across 510(k)s cleared under the name Baxter Healthcare Corp is 85 days. Since 2017: 129 days, versus 143 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Baxter Healthcare Corp?

The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 67); FRN (Pump, Infusion, 51); KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 26).

Next steps

• See all 568 Baxter Healthcare Corp clearances with predicates and recalls
• Run predicate analysis for product code FPA, Baxter Healthcare 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.

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