U.S. Mfg. & Management, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “U.S. Mfg. & Management, Inc.” (first 1984, latest 1992), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 37 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 |
|---|---|---|---|
| BXB | Exerciser, Powered | 1 | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 | 1 |
| KSS | Supplies, Blood-Bank | 1 | 1 |
Plus 1 more product codes.
Review panels
- Hematology (1)
- General Hospital (1)
- Physical Medicine (1)
Most recent U.S. Mfg. & Management, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K920860 | CONTROLLED PASSIVE MOTION MACHINE | BXB | 1992-04-02 | 37 |
| K874436 | FLUID SAMPLING PACK | KSS | 1988-01-05 | 69 |
| K862335 | MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT | — | 1986-07-24 | 35 |
| K853242 | I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI | — | 1985-08-30 | 29 |
| K842999 | VENI-SHIELD | KMK | 1984-09-24 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named U.S. Mfg. & Management, 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 U.S. Mfg. & Management, Inc.?
FDA lists 5 510(k) clearances under the applicant name “U.S. Mfg. & Management, Inc.” (first 1984, latest 1992), across 4 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 U.S. Mfg. & Management, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name U.S. Mfg. & Management, Inc. is 37 days.
Which FDA product codes appear under U.S. Mfg. & Management, Inc.?
The most frequent FDA product codes under this applicant name are BXB (Exerciser, Powered, 1); KMK (Device, Intravascular Catheter Securement, 1); KSS (Supplies, Blood-Bank, 1).
Next steps
- See all 5 U.S. Mfg. & Management, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BXB, U.S. Mfg. & Management, 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.