Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LWF — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
549 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181219 | OptiPillows EPAP Mask | Cpapnea Medical Supply | 2018-08-03 | 88 | 0 |
| K120665 | INVENT SNORING DEVICE | Ventus Medical, Inc. | 2012-06-12 | 99 | 0 |
| K040491 | CHIN-UP STRIP | Dale Miller, Inc. - the Chin-Up Company | 2004-09-10 | 197 | 0 |
| K982929 | MAXAIR NASAL DILATOR SYSTEM | Hnl Technologies | 1998-09-09 | 20 | 0 |
| K963326 | BREATHE FIT | Cambridge Assoc. | 1997-02-12 | 173 | 0 |
| K962400 | AIR MAX EXTERNAL NASAL DILATOR STRIP | American White Cross, Inc. | 1996-09-09 | 80 | 0 |
| K962698 | ACUTEK'S CLEARPASAGE | Acutek Adhesive Specialties, Inc. | 1996-09-09 | 84 | 0 |
| K955711 | BREATHE RIGHT NASAL STRIP | Cns, Inc. | 1996-05-30 | 164 | 0 |
| K954914 | BREATHE RIGHT NASAL STRIP | Cns, Inc. | 1996-02-27 | 124 | 0 |
| K955233 | EASY BREATHING NASAL STRIPS | Corbett Lair, Inc. | 1995-12-21 | 37 | 0 |
| K953042 | E-Z BREATHERS | E-Z Kare Good Health Systems, Inc. | 1995-12-08 | 176 | 0 |
| K942025 | BURGET NASAL STENT | Bivona Medical Technologies | 1995-10-27 | 549 | 0 |
| K953772 | BREATHE RIGHT NASAL STRIP | Cns, Inc. | 1995-10-20 | 67 | 0 |
| K954252 | EASY BREATHING NASAL STRIPS | Corbett Lair, Inc. | 1995-10-18 | 37 | 0 |
| K951644 | ACUTEK'S CLEARPASSAGE | Acutek Adhesive Specialties, Inc. | 1995-07-03 | 84 | 0 |
| K921220 | BREATHE RIGHT | Cns, Inc. | 1993-10-07 | 573 | 0 |
| K904290 | NOZOVENT, NASAL DILATOR | Wpm Intl AB Intl Trade & Managemet Consulting | 1991-08-20 | 337 | 0 |
| K882131 | NOSE BRACE | Allied Advanced Technologies (Aat) | 1988-07-15 | 56 | 0 |
| K874089 | BREATHE WITH EEZ (NASAL DILATOR) | Breathe With Eez Corp. | 1987-12-23 | 77 | 0 |
| K862406 | NOZEES NOSTRIL DILATOR | Nozees Co. | 1986-09-19 | 86 | 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