Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Universal Medical Instrument Corp. · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
90 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962180 | CATH SEAL | Universal Medical Instrument Corp. | 1996-11-07 | 154 | 0 |
| K935077 | CATH-SEAL | Universal Medical Instrument Corp. | 1994-06-07 | 228 | 0 |
| K897128 | UMI BRAIDED CATHETER CONNECTOR | Universal Medical Instrument Corp. | 1990-03-01 | 65 | 0 |
| K881796 | UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE | Universal Medical Instrument Corp. | 1988-07-26 | 90 | 0 |
| K863178 | UMI STEERABLE TORQUE GUIDE WIRE | Universal Medical Instrument Corp. | 1986-09-19 | 32 | 0 |
| K861984 | UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO | Universal Medical Instrument Corp. | 1986-08-05 | 75 | 0 |
| K860168 | UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE | Universal Medical Instrument Corp. | 1986-02-19 | 33 | 0 |
| K851088 | UMI ANGIOGRAPHIC CATHETER | Universal Medical Instrument Corp. | 1985-05-16 | 59 | 0 |
| K850820 | PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID | Universal Medical Instrument Corp. | 1985-04-10 | 41 | 0 |
| K844558 | UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE | Universal Medical Instrument Corp. | 1985-01-31 | 71 | 0 |
| K842259 | PCI W/CATH-SEAL SIDE FLOW FITTING | Universal Medical Instrument Corp. | 1984-08-01 | 55 | 0 |
| K842012 | UMI CURVED CHEMONUCLEOLYSIS NEEDLE | Universal Medical Instrument Corp. | 1984-07-06 | 50 | 0 |
| K834436 | CHEMONUCLEOLYSIS NEEDLE | Universal Medical Instrument Corp. | 1984-03-15 | 87 | 0 |
| K833937 | UMI PERCUTANEOUS TRANSHEPATIC CHOLAN | Universal Medical Instrument Corp. | 1984-01-03 | 49 | 0 |
| K832193 | NICE PACK | Universal Medical Instrument Corp. | 1983-08-31 | 54 | 0 |
| K830019 | AMNIO CENTESES KIT W/NEEDLE | Universal Medical Instrument Corp. | 1983-01-18 | 14 | 0 |
| K822586 | TEFLON COATED GUIDE WIRES & CATHETER | Universal Medical Instrument Corp. | 1982-10-18 | 53 | 0 |
| K822290 | STERILE PROTECTIVE SLEEVE W/TOUGH-BORST | Universal Medical Instrument Corp. | 1982-08-31 | 29 | 0 |
| K822247 | CATH-SEAL | Universal Medical Instrument Corp. | 1982-08-19 | 21 | 0 |
| K812999 | PET POLYETHYLENE TORQUE CATHETER | Universal Medical Instrument Corp. | 1981-11-16 | 21 | 0 |
| K770569 | CATHETER, EMBOLECTOMY, UMI | Universal Medical Instrument Corp. | 1977-04-05 | 11 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda