Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KAM — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
280 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110687 | RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) | Acclarent, Inc. | 2011-10-07 | 210 | 0 |
| K093594 | MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER | Acclarent, Inc. | 2010-03-03 | 104 | 0 |
| K083574 | RELIEVA STRATUS MICROFLOW SPACER | Acclarent, Inc. | 2009-01-29 | 57 | 0 |
| K072891 | SINUS SPACER | Acclarent, Inc. | 2008-03-19 | 161 | 0 |
| K073041 | RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER | Acclarent, Inc. | 2008-03-11 | 134 | 0 |
| K071845 | RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A | Acclarent, Inc. | 2007-09-28 | 85 | 0 |
| K062458 | ETHMOID SINUS SPACER | Acclarent, Inc. | 2006-09-15 | 23 | 0 |
| K060974 | RELIENT NAVIGATION DEVICE | Acclarent, Inc. | 2006-05-05 | 25 | 0 |
| K050340 | MICROMEDICS SPHENOID SINUS STENT | Micromedics, Inc. | 2005-04-27 | 75 | 0 |
| K994262 | FRONTAL SINUS TREPHINATION CANNULA | Xomed, Inc. | 2000-02-08 | 53 | 0 |
| K973273 | XOMED T-STENT, FRONTAL SINUS STENT | Xomed, Inc. | 1997-09-29 | 27 | 0 |
| K951803 | ROSSITER SINUS STENT | Smith & Nephew Richards, Inc. | 1995-05-11 | 22 | 0 |
| K951066 | RAINS FRONTAL SINUS STENT | Smith & Nephew Richards, Inc. | 1995-04-04 | 27 | 0 |
| K942495 | SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM | Atos Medical AB | 1995-02-21 | 280 | 0 |
| K922902 | SALMAN SINUS BUTTON | Boston Medical Products, Inc. | 1993-05-18 | 336 | 0 |
| K922145 | SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS | Atos Medical AB | 1993-01-21 | 259 | 0 |
| K912418 | SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE | Micromedics, Inc. | 1991-12-20 | 203 | 0 |
| K896630 | SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM | Atos Medical AB | 1990-06-06 | 196 | 0 |
| K813474 | MAXILL-AIR SINUS VENTILATION TUBE | Xomed, Inc. | 1982-01-12 | 42 | 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