Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Keymed, Inc. — Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
250 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100803 | OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 | Keymed, Inc. | 2010-04-22 | 31 | 0 |
| K921179 | OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 | Keymed, Inc. | 1993-03-29 | 385 | 0 |
| K881004 | OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR | Keymed, Inc. | 1988-05-12 | 64 | 0 |
| K861821 | KEYMED FIBERSCOPE AUTO DISINFECTOR | Keymed, Inc. | 1987-02-12 | 276 | 0 |
| K864801 | THE KEYMED HI-LIGHT 250 LIGHT SOURCE | Keymed, Inc. | 1986-12-24 | 15 | 0 |
| K862000 | KEYMED FLEXIBLE ESOPHAGEAL DILATORS | Keymed, Inc. | 1986-08-12 | 81 | 0 |
| K860528 | THE KEYMED FIBERSCOPE STERILIZATION CASE | Keymed, Inc. | 1986-07-15 | 154 | 0 |
| K861147 | UCS-2, ULTRASONIC CLEANING SOLUTION | Keymed, Inc. | 1986-06-23 | 89 | 0 |
| K860704 | THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND | Keymed, Inc. | 1986-06-17 | 111 | 0 |
| K851149 | KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 | Keymed, Inc. | 1985-11-26 | 250 | 0 |
| K854304 | KEYMED OFFICE COUCH | Keymed, Inc. | 1985-11-12 | 18 | 0 |
| K853421 | THE KEYMED VARI-HEIGHT PATIENT COUCH | Keymed, Inc. | 1985-09-19 | 36 | 0 |
| K841822 | KEYMED SIGMOIDOSCOPE SUCTION UNIT | Keymed, Inc. | 1984-07-27 | 86 | 0 |
| K841331 | OLYMPUS KC-10 MOBILE DISINFEC-STAT | Keymed, Inc. | 1984-07-19 | 108 | 0 |
| K841399 | BRONCHOSCOPE SUCTION UNIT | Keymed, Inc. | 1984-07-18 | 106 | 0 |
| K840920 | KEYMED MOBILE ENDOSCOPY PATIENT COUCH | Keymed, Inc. | 1984-03-19 | 18 | 0 |
| K830586 | TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR | Keymed, Inc. | 1983-03-24 | 29 | 0 |
| K830247 | SPLIT COLON STIFFENING TUBE | Keymed, Inc. | 1983-03-15 | 49 | 0 |
| K830026 | FIBERSCOPE DISINFECTANT IRRIGATOR | Keymed, Inc. | 1983-01-14 | 10 | 0 |
| K822401 | ST. MARK'S RECTAL BIOPSY FORCEPS | Keymed, Inc. | 1982-08-27 | 17 | 0 |
| K820739 | KEYMED KEY VAC SUCTION PUMP | Keymed, Inc. | 1982-05-21 | 64 | 0 |
| K820652 | EXHALED HYDROGEN MONITOR | Keymed, Inc. | 1982-04-01 | 23 | 0 |
| K813325 | KEY MED FOREIGN BODY REMOVAL TUBE | Keymed, Inc. | 1982-02-10 | 78 | 0 |
| K820152 | KEY MED LEEDS ENDOSCOPE DISINFECTOR | Keymed, Inc. | 1982-01-29 | 10 | 0 |
| K813133 | KEYMED KEY LIGHT | Keymed, Inc. | 1981-11-20 | 15 | 0 |
| K810818 | KEY-MED FIBRESCOPE DISINFECTION TROLLEY | Keymed, Inc. | 1981-04-08 | 15 | 0 |
| K810392 | OESOPHAGEAL THERAPY KIT | Keymed, Inc. | 1981-03-31 | 42 | 0 |
| K810393 | ENDOSCOPIC CLOSED CIRCUIT COLOR TV SYST. | Keymed, Inc. | 1981-03-02 | 13 | 0 |
| K810180 | WILLIAMS OESOPHAGEAL VARICES INJECT TUBE | Keymed, Inc. | 1981-02-09 | 18 | 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