Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clarus Medical Systems, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
186 daysmedian FDA review time
407 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980588 | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 | Clarus Medical Systems, Inc. | 1998-08-18 | 182 | 0 |
| K974579 | PERCSCOPE MODEL 2600 | Clarus Medical Systems, Inc. | 1998-02-18 | 72 | 0 |
| K971584 | CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERI | Clarus Medical Systems, Inc. | 1997-05-23 | 23 | 0 |
| K971455 | CLARUS MODEL 5197 SIGHTLITE | Clarus Medical Systems, Inc. | 1997-05-20 | 29 | 0 |
| K960915 | CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX | Clarus Medical Systems, Inc. | 1996-12-24 | 293 | 0 |
| K962255 | CLARUS MURPHYPEN ENDOSCOPE(2127-XXX) | Clarus Medical Systems, Inc. | 1996-09-11 | 91 | 0 |
| K955598 | CLARUS SPINEPEN MODEL 2126 | Clarus Medical Systems, Inc. | 1996-02-06 | 60 | 0 |
| K953685 | INSTRUMENT SCOPE | Clarus Medical Systems, Inc. | 1995-10-12 | 66 | 0 |
| K945633 | NEURO CHANNEL ENDOSCOPE MODEL 2232 | Clarus Medical Systems, Inc. | 1995-09-19 | 307 | 1 |
| K945296 | CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160 | Clarus Medical Systems, Inc. | 1995-07-14 | 256 | 0 |
| K941188 | CLARUS NEURO ENDOSCOPE (MODEL 2230) | Clarus Medical Systems, Inc. | 1995-04-25 | 407 | 0 |
| K940144 | CLARUS PHOENIX ENDOSCOPE | Clarus Medical Systems, Inc. | 1995-04-25 | 469 | 0 |
| K942413 | CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR | Clarus Medical Systems, Inc. | 1994-11-22 | 186 | 0 |
| K942249 | CLARUS NEUROPEN MODEL 2120 | Clarus Medical Systems, Inc. | 1994-11-04 | 179 | 0 |
| K923514 | CLARUS SERIES 2100 ENDOSCOPE | Clarus Medical Systems, Inc. | 1994-01-07 | 540 | 0 |
| K932259 | CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE | Clarus Medical Systems, Inc. | 1993-12-15 | 239 | 0 |
| K925741 | CLARUS ENDOSCOPIC HOOK KNIFE | Clarus Medical Systems, Inc. | 1993-08-24 | 284 | 0 |
| K925742 | CLARUS CHOLANGIOGRAM CATHETER KIT | Clarus Medical Systems, Inc. | 1993-06-01 | 200 | 0 |
| K926048 | CLARUS ENDOSCOPIC BALL PROBE | Clarus Medical Systems, Inc. | 1993-04-07 | 127 | 0 |
| K924554 | CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE | Clarus Medical Systems, Inc. | 1993-02-25 | 169 | 0 |
| K915725 | CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE | Clarus Medical Systems, Inc. | 1992-11-16 | 332 | 0 |
| K922881 | CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC | Clarus Medical Systems, Inc. | 1992-11-16 | 153 | 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