Pharmaseal Div., Baxter Healthcare Corp.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Pharmaseal Div., Baxter Healthcare Corp.” (first 1976, latest 1979), across 17 product codes in 7 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 3 | 3 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 3 | 3 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 | 2 |
| JBQ | Antithrombin Iii Quantitation | 2 | 2 |
| KOD | Catheter, Urological | 2 | 2 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| FMA | Depressor, Tongue, Non-Surgical | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
Plus 7 more product codes.
Review panels
- General Hospital (9)
- Gastroenterology and Urology (5)
- Cardiovascular (3)
- General and Plastic Surgery (3)
- Hematology (2)
- Anesthesiology (1)
- Obstetrics and Gynecology (1)
Most recent Pharmaseal Div., Baxter Healthcare Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K792369 | HYPERALIMENTATION DRESSING TRAY | FRG | 1979-12-10 | 77 |
| K792141 | CONTINUOUS FLUSH DEVICE | KRA | 1979-12-05 | 44 |
| K792019 | PHADECODE XA INHIBITOR ASSAY | JBQ | 1979-11-05 | 27 |
| K791773 | VENTILATOR TUBE WITH FILTER | CAH | 1979-10-22 | 42 |
| K791156 | AMIPAQUE MYELOGRAM TRAY | FMI | 1979-07-30 | 39 |
| K790896 | TWO-WAY ANESTHESIA FILTER | CAH | 1979-06-05 | 28 |
| K790409 | LOW DEAD SPACE INSULIN SYRINGE | FMF | 1979-04-24 | 57 |
| K782069 | TRAY, AUXILLARY BLOCK | CAZ | 1979-01-04 | 22 |
| K781797 | PREP TRAY, PREOPERATIVE SKIN | OJU | 1978-11-08 | 16 |
| K781680 | MONITORING, PRESSURE KIT | DRS | 1978-10-06 | 4 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pharmaseal Div., Baxter Healthcare Corp..
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 Pharmaseal Div., Baxter Healthcare Corp. (a text match, not an official crosswalk):
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.
- Pharmaseal Laboratories (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pharmaseal Div., Baxter Healthcare Corp.?
FDA lists 24 510(k) clearances under the applicant name “Pharmaseal Div., Baxter Healthcare Corp.” (first 1976, latest 1979), across 17 product codes in 7 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 Pharmaseal Div., Baxter Healthcare Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pharmaseal Div., Baxter Healthcare Corp. is 28 days.
Which FDA product codes appear under Pharmaseal Div., Baxter Healthcare Corp.?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 3); KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 3); CAH (Filter, Bacterial, Breathing-Circuit, 2).
Next steps
- See all 24 Pharmaseal Div., Baxter Healthcare Corp. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Pharmaseal Div., 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.