Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xomed, Inc. — Predicate Candidate Screening
82 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
47 daysmedian FDA review time
126 days90th percentile
82clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002395 | MODEL 30 CLASSIC PNEUMATONOMETER | Xomed, Inc. | 2000-12-11 | 126 | 0 |
| K002987 | REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE | Xomed, Inc. | 2000-12-04 | 70 | 0 |
| K002828 | XPS NITRO SYSTEM | Xomed, Inc. | 2000-10-17 | 36 | 1 |
| K002897 | TITANIUM MIDDLE EAR PROSTHESES | Xomed, Inc. | 2000-10-11 | 23 | 1 |
| K993653 | MICRO-FRANCE TROCARS AND ACCESSORIES | Xomed, Inc. | 2000-06-09 | 224 | 0 |
| K001148 | MEROGEL OTOLOGIC PACK | Xomed, Inc. | 2000-06-03 | 54 | 0 |
| K994262 | FRONTAL SINUS TREPHINATION CANNULA | Xomed, Inc. | 2000-02-08 | 53 | 0 |
| K992855 | XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS P | Xomed, Inc. | 2000-01-21 | 150 | 0 |
| K993582 | MODIFICATION TO LASER-SHIELD II | Xomed, Inc. | 2000-01-20 | 90 | 0 |
| K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | Xomed, Inc. | 1999-12-21 | 53 | 2 |
| K993112 | XOMED ENT RF SYSTEM | Xomed, Inc. | 1999-12-09 | 83 | 0 |
| K992869 | XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE | Xomed, Inc. | 1999-10-07 | 43 | 0 |
| K992282 | MICRO-FRANCE LIPOSUCTION CANNULAS | Xomed, Inc. | 1999-09-23 | 78 | 0 |
| K984363 | XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 | Xomed, Inc. | 1999-02-26 | 81 | 0 |
| K982731 | MEROGEL NASAL DRESSING AND SINUS STENT | Xomed, Inc. | 1999-02-02 | 181 | 0 |
| K983025 | XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT | Xomed, Inc. | 1998-11-06 | 67 | 0 |
| K982870 | EPIFILM OTOLOGIC LAMINA | Xomed, Inc. | 1998-11-03 | 81 | 0 |
| K983224 | XPS DRILL SYSTEM | Xomed, Inc. | 1998-10-21 | 37 | 0 |
| K982294 | XOMED SILICONE PRE-FORM BLOCKS | Xomed, Inc. | 1998-09-18 | 80 | 0 |
| K982595 | NIM4 | Xomed, Inc. | 1998-09-04 | 39 | 0 |
| K982594 | ENDO-SCRUB/ENDO-SCRUB 2 | Xomed, Inc. | 1998-08-27 | 34 | 1 |
| K973499 | XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM | Xomed, Inc. | 1998-01-30 | 136 | 0 |
| K973273 | XOMED T-STENT, FRONTAL SINUS STENT | Xomed, Inc. | 1997-09-29 | 27 | 0 |
| K972453 | XPS STRAIGHTSHOT MICRORESECTOR | Xomed, Inc. | 1997-09-05 | 67 | 0 |
| K971124 | TM MICRO-CATHETERS | Xomed, Inc. | 1997-05-16 | 50 | 0 |
| K970910 | XOMED SILICONE BLOCK/STRIP | Xomed, Inc. | 1997-05-02 | 51 | 0 |
| K965233 | SHARPSITE AC | Xomed, Inc. | 1997-04-04 | 94 | 0 |
| K964909 | ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS | Xomed, Inc. | 1997-03-10 | 91 | 0 |
| K964484 | KARTUSH TM PATCHER | Xomed, Inc. | 1997-01-24 | 78 | 0 |
| K961873 | ACTIVENT ANTIMICROBIAL VENTILATION TUBES | Xomed, Inc. | 1996-07-01 | 47 | 0 |
| K960853 | ACE SYSTEM | Xomed, Inc. | 1996-04-03 | 33 | 0 |
| K901016 | LASER-SHIELD II(TM) | Xomed, Inc. | 1990-08-29 | 177 | 0 |
| K884631 | FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135) | Xomed, Inc. | 1989-03-22 | 135 | 0 |
| K884834 | XOMED IONESTHETIZER(TM) | Xomed, Inc. | 1989-02-15 | 89 | 0 |
| K884056 | MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR | Xomed, Inc. | 1988-11-30 | 65 | 0 |
| K882689 | PUNCH MYRINGOTOMY SYSTEM | Xomed, Inc. | 1988-09-13 | 75 | 0 |
| K881382 | XOMED AUDIANT BONE CONDUCTOR | Xomed, Inc. | 1988-06-21 | 81 | 0 |
| K875277 | ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON. | Xomed, Inc. | 1988-03-14 | 81 | 0 |
| K872112 | XOMED PLATINUM WIRE TEFLON PISTION | Xomed, Inc. | 1987-07-02 | 31 | 0 |
| K872168 | XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO. | Xomed, Inc. | 1987-06-30 | 22 | 0 |
| K861971 | XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL | Xomed, Inc. | 1986-05-30 | 9 | 0 |
| K855059 | AUDIANT BONE CONDUCTOR OR A.B.C. | Xomed, Inc. | 1986-04-03 | 106 | 0 |
| K860491 | OSTEO-MESH CRANIAL FAIRING | Xomed, Inc. | 1986-03-28 | 46 | 0 |
| K852387 | GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE | Xomed, Inc. | 1986-01-06 | 215 | 0 |
| K853641 | GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE | Xomed, Inc. | 1986-01-06 | 125 | 0 |
| K832404 | RECTAL TEMP. TELEMETRY MONITOR | Xomed, Inc. | 1983-09-12 | 54 | 0 |
| K831127 | INTRA-ORAL ARTIFICIAL LARYNX | Xomed, Inc. | 1983-07-28 | 113 | 0 |
| K822790 | MICRO-CRAFT OSCILLATING SAW HANDPIECE | Xomed, Inc. | 1982-10-22 | 37 | 0 |
| K821904 | XOMED MANDIBULAR TRAY | Xomed, Inc. | 1982-07-26 | 28 | 0 |
| K821373 | XOMED PATENCY MONITOR | Xomed, Inc. | 1982-07-08 | 59 | 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