Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BTQ — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
32 daysmedian FDA review time
154 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940320 | AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS | Ad-Tech Medical Instrument Corp | 1995-09-19 | 603 | 0 |
| K921353 | NASOPHARYNGEAL AIRWAY | Coast Medical Corp. | 1992-06-11 | 84 | 0 |
| K911784 | NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY | North American Sterilization & Packaging Co. | 1991-09-23 | 154 | 0 |
| K903618 | ROBERTAZZI NASOPHARYNGEAL AIRWAY | Eastmed Enterprises, Inc. | 1991-01-08 | 154 | 0 |
| K900456 | POLAMEDCO NASOPAHARYNGEAL AIRWAY | Polamedco, Inc. | 1990-04-19 | 79 | 0 |
| K901279 | CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY | Chatham Industries | 1990-03-28 | 9 | 0 |
| K883668 | SUNDERLAND NASAL TUBE | Exmoor Plastics , Ltd. | 1988-11-21 | 87 | 0 |
| K873949 | RORERTAZZI NASOPHARYNGEAL AIRWAY | Penn Medical Devices, Inc. | 1987-10-20 | 22 | 0 |
| K871673 | NASOPHARYNGEAL AIRWAY | Harding Industries, Inc. | 1987-06-15 | 48 | 0 |
| K853162 | STERILE NASOPHARYNGEAL AIRWAY | Inmed Corp. | 1985-08-06 | 7 | 0 |
| K850644 | NASOPHARYNGEAL AIRWAY-ROBERTAZZI | Dryden Corp. | 1985-03-21 | 30 | 0 |
| K843524 | LINDER NASOPHARYNGEAL AIRWAY | Polamedco, Inc. | 1984-10-04 | 28 | 0 |
| K841093 | NASOPHARYNGEAL AIRWAYS | Inmed Corp. | 1984-03-23 | 10 | 0 |
| K834078 | SILICONE RUGGER DISPOSABLE YOKE-CPAP | Vesta, Inc. | 1983-12-27 | 29 | 0 |
| K831476 | NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLE | Fls Medical Products, Inc. | 1983-06-10 | 32 | 0 |
| K830983 | AIRWAYS & NASOPHARYNGEAL TYPE | Medovations, Inc. | 1983-05-09 | 41 | 0 |
| K810960 | NASOPHARYNGEAL AIRWAY | Vesta, Inc. | 1981-04-23 | 15 | 0 |
| K792018 | SILICONE RUBBER-BI NASOPHARYNGEAL AIR | Vesta, Inc. | 1979-11-13 | 35 | 0 |
| K760125 | AIRWAY, ARGYLE NASOPHARYNGEAL | Sherwood Medical Industries | 1976-07-19 | 21 | 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