Klein-Baker Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Klein-Baker Medical, Inc.” (first 1996, latest 1997), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| FOS | Catheter, Umbilical Artery | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 1 | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
| MIA | Needle, Spinal, Short Term | 1 | 1 |
Review panels
Most recent Klein-Baker Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972731 | NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET | KDJ | 1997-09-29 | 69 |
| K970997 | NEO-CARE LUMBER PUNCTURE KIT | MIA | 1997-05-22 | 64 |
| K970434 | NEO-PICC | LJS | 1997-04-01 | 55 |
| K963972 | NEO-CARE DUAL LUMEN UMBILICAL CATHETER | FOS | 1996-12-24 | 82 |
| K963867 | NEO-CARE CATHETERIZATION TRAY | FOZ | 1996-11-06 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Klein-Baker Medical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Klein-Baker Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Klein-Baker Medical, Inc.” (first 1996, latest 1997), across 5 product codes in 3 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 Klein-Baker Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Klein-Baker Medical, Inc. is 64 days.
Which FDA product codes appear under Klein-Baker Medical, Inc.?
The most frequent FDA product codes under this applicant name are FOS (Catheter, Umbilical Artery, 1); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1); KDJ (Set, Administration, For Peritoneal Dialysis, Disposable, 1).
Next steps
- See all 5 Klein-Baker Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FOS, Klein-Baker Medical, 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.