Universal Medical Instrument Corp.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Universal Medical Instrument Corp.” (first 1977, latest 1996), across 11 product codes in 5 review panels. Median 510(k) review time under this name: 53 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | 6 | 6 |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| DQX | Wire, Guide, Catheter | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 2 | 2 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| DXE | Catheter, Embolectomy | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| IME | Pack, Hot Or Cold, Reusable | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (13)
- General Hospital (3)
- Obstetrics and Gynecology (2)
- Gastroenterology and Urology (1)
- Physical Medicine (1)
Most recent Universal Medical Instrument Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962180 | CATH SEAL | DYB | 1996-11-07 | 154 |
| K935077 | CATH-SEAL | DYB | 1994-06-07 | 228 |
| K897128 | UMI BRAIDED CATHETER CONNECTOR | LYY | 1990-03-01 | 65 |
| K881796 | UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE | DWS | 1988-07-26 | 90 |
| K863178 | UMI STEERABLE TORQUE GUIDE WIRE | DQX | 1986-09-19 | 32 |
| K861984 | UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO | DYB | 1986-08-05 | 75 |
| K860168 | UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE | — | 1986-02-19 | 33 |
| K851088 | UMI ANGIOGRAPHIC CATHETER | DQO | 1985-05-16 | 59 |
| K850820 | PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID | DYB | 1985-04-10 | 41 |
| K844558 | UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE | HIO | 1985-01-31 | 71 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Universal Medical Instrument 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.
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.
- Universal Medical, Inc. (8 510(k)s)
- Universal Reagents, Inc. (8 510(k)s)
- Universal Gloves Corp. (3 510(k)s)
- Universal Prosthetics, Inc. (3 510(k)s)
- Universal Technology Systems, Inc. (3 510(k)s)
- Universal Gym Equipment, Inc. (2 510(k)s)
- Universal Health Care Products Canada, Inc. (2 510(k)s)
- Universal Implant Systems, Inc. (2 510(k)s)
- Universal Instruments Corp. (2 510(k)s)
- Universal Biosensors Pty, Ltd. (1 510(k)s)
- Universal Bodycare (I) Sdn. Bhd. (1 510(k)s)
- Universal Brain (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Universal Medical Instrument Corp.?
FDA lists 21 510(k) clearances under the applicant name “Universal Medical Instrument Corp.” (first 1977, latest 1996), across 11 product codes in 5 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 Universal Medical Instrument Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Universal Medical Instrument Corp. is 53 days.
Which FDA product codes appear under Universal Medical Instrument Corp.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 6); DQO (Catheter, Intravascular, Diagnostic, 3); DQX (Wire, Guide, Catheter, 2).
Next steps
- See all 21 Universal Medical Instrument Corp. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Universal Medical Instrument 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.