Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
EQN — Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
21 daysmedian FDA review time
170 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and Accessories | KARL STORZ Endoscopy-America, Inc. | 2026-05-15 | 270 | 0 |
| K150248 | ORL Video NasoPharyngo-Larngoscope | Jedmed Instrument Company | 2015-07-23 | 170 | 0 |
| K132039 | ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM | Jedmed Instrument Co. | 2014-02-21 | 234 | 0 |
| K834172 | OP-CON SURG. INSTRUMENT #7 | Imm Enterprises , Ltd. | 1984-03-06 | 106 | 0 |
| K831255 | LARYNGOSCOPE ATTACHMENT PH2000 | Eder Instrument Co, Inc. | 1983-09-12 | 147 | 0 |
| K830888 | COOL-LITE FIBERCOPTIC LARYNGEAL EXAM | National Medical Technology | 1983-04-27 | 37 | 0 |
| K822525 | LARYNGOSCOPES RIGID | Kelleher Corp. | 1982-09-09 | 17 | 0 |
| K821707 | NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT | Kelleher Corp. | 1982-06-25 | 16 | 0 |
| K821708 | NAGASHIMA LIGHT SOURCE UNIT SL-4 | Kelleher Corp. | 1982-06-25 | 16 | 0 |
| K821709 | NAGASHIMA LIGHT SOURCE UNIT SL-5 | Kelleher Corp. | 1982-06-25 | 16 | 0 |
| K821706 | NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL | Kelleher Corp. | 1982-06-25 | 16 | 0 |
| K821710 | NAGASHIMA NX-150F LIGHT SOURCE UNIT | Kelleher Corp. | 1982-06-25 | 16 | 0 |
| K821269 | TRACHEOSTOMY CARE TRAYS | Intermed, Inc. | 1982-05-27 | 24 | 0 |
| K821182 | MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- | Machida America, Inc. | 1982-05-13 | 16 | 0 |
| K821181 | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE # | Machida America, Inc. | 1982-05-13 | 16 | 0 |
| K813297 | CONPHAR LARYNGOSCOPE | Conphar, Inc. | 1982-01-22 | 60 | 0 |
| K812734 | MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P | Machida America, Inc. | 1981-10-19 | 20 | 0 |
| K811943 | MACHIDA NASOPHARYNGO-LARYNGOSCOPE | Machida America, Inc. | 1981-07-28 | 21 | 0 |
| K792222 | SHILEY LOW PRESSURE THIN-CUFFED TRACH. | Shiley, Inc. | 1979-12-18 | 43 | 0 |
| K782002 | TRACH-COLLAR | Kinetic Concepts, Inc. | 1978-12-15 | 11 | 0 |
| K781639 | SHILEY CRICOTHYROTOMY TUBE | Shiley, Inc. | 1978-10-24 | 33 | 0 |
| K770085 | ROBBETT MICROSURGICAL LARYNGOSCOPE | Edward Weck, Inc. | 1977-01-21 | 7 | 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