Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Somnus Medical Technologies, Inc. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
308 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000720 | SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS RE | Somnus Medical Technologies, Inc. | 2000-05-30 | 88 | 0 |
| K001438 | SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR | Somnus Medical Technologies, Inc. | 2000-05-16 | 8 | 0 |
| K000501 | ELECTROSURGICAL GENERATOR, MODEL S1 | Somnus Medical Technologies, Inc. | 2000-03-17 | 31 | 0 |
| K982717 | SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000 | Somnus Medical Technologies, Inc. | 1998-11-02 | 90 | 0 |
| K973701 | SOMNUS TISSUE COAGULATING ELECTRODE | Somnus Medical Technologies, Inc. | 1998-01-30 | 123 | 0 |
| K970838 | SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTROD | Somnus Medical Technologies, Inc. | 1998-01-09 | 308 | 0 |
| K970837 | SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE | Somnus Medical Technologies, Inc. | 1998-01-09 | 308 | 0 |
| K973618 | SOMNOPLASTY SYSTEM | Somnus Medical Technologies, Inc. | 1997-12-19 | 87 | 0 |
| K971450 | SOMNOPLASTY SYSTEM | Somnus Medical Technologies, Inc. | 1997-07-17 | 87 | 0 |
| K971711 | SOMNUS MODEL 215 ELECTROSURGICAL GENERATOR | Somnus Medical Technologies, Inc. | 1997-06-24 | 47 | 0 |
| K970809 | BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL | Somnus Medical Technologies, Inc. | 1997-06-18 | 105 | 0 |
| K970576 | SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615) | Somnus Medical Technologies, Inc. | 1997-04-09 | 55 | 0 |
| K963884 | SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL | Somnus Medical Technologies, Inc. | 1996-12-16 | 81 | 0 |
| K963772 | SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225) | Somnus Medical Technologies, Inc. | 1996-10-23 | 34 | 0 |
| K961133 | SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE | Somnus Medical Technologies, Inc. | 1996-07-10 | 111 | 0 |
| K961132 | SOMNUS MEDICAL TECH SOFT TISSUE COAGULATING ELECTRODE | Somnus Medical Technologies, Inc. | 1996-05-22 | 62 | 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