Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Polamedco, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
426 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983000 | CRICOTHYROTOMY TUBE | Polamedco, Inc. | 1999-10-27 | 426 | 0 |
| K954383 | SURELOC CIRCUIT CONNECTOR | Polamedco, Inc. | 1995-12-22 | 94 | 0 |
| K953793 | INTROSCOPE | Polamedco, Inc. | 1995-11-29 | 107 | 0 |
| K950713 | AIRGUIDE STYLETTE | Polamedco, Inc. | 1995-05-17 | 91 | 0 |
| K933596 | GASTRIC, CATHETER, IRRIGATION & ASPIRATION | Polamedco, Inc. | 1995-02-13 | 567 | 0 |
| K950380 | FLEXTITIP STYLETTE | Polamedco, Inc. | 1995-02-10 | 10 | 0 |
| K920900 | POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES | Polamedco, Inc. | 1992-03-18 | 21 | 0 |
| K900456 | POLAMEDCO NASOPAHARYNGEAL AIRWAY | Polamedco, Inc. | 1990-04-19 | 79 | 0 |
| K900457 | CUFFED LINDER NASOTRACHEAL AIRWAY | Polamedco, Inc. | 1990-04-16 | 76 | 0 |
| K894516 | VISOSHIELD(TM), SURGICAL EYE PROTECTOR | Polamedco, Inc. | 1989-09-12 | 55 | 0 |
| K881496 | LINDER NASOTRACHEAL AIRWAY | Polamedco, Inc. | 1988-05-31 | 53 | 0 |
| K843524 | LINDER NASOPHARYNGEAL AIRWAY | Polamedco, Inc. | 1984-10-04 | 28 | 0 |
| K821933 | OMNISURG SIDE MOUNTING CLAMP & RAIL EXT. | Polamedco, Inc. | 1982-07-08 | 9 | 0 |
| K812943 | SLICK ENDOTRACHEAL TUBE | Polamedco, Inc. | 1981-11-06 | 17 | 0 |
| K810151 | SLICK SET W/SURELOC EXTERNAL CONNECTOR | Polamedco, Inc. | 1981-02-12 | 22 | 0 |
| K810150 | OMNISURG WORKING INSTRUMENT TABLE | Polamedco, Inc. | 1981-02-12 | 22 | 0 |
| K791532 | SURELOC EXTERNAL CONNECTOR | Polamedco, Inc. | 1979-09-04 | 25 | 0 |
| K781808 | SLICK SET, CUFFED | Polamedco, Inc. | 1978-11-29 | 37 | 0 |
| K780900 | SLICK SET | Polamedco, Inc. | 1978-07-17 | 63 | 27 |
| K780587 | GYNESURG | Polamedco, Inc. | 1978-05-25 | 44 | 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