Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Richard Wolf Medical Instruments Corporation · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
165 daysmedian FDA review time
284 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231291 | Perforated Baskets | Richard Wolf Medical Instruments Corporation | 2024-06-03 | 396 | 0 |
| K230194 | HF Surgery Generator 400KHZ | Richard Wolf Medical Instruments Corporation | 2023-03-22 | 57 | 0 |
| K212808 | Logic Hd camera head green, System green | Richard Wolf Medical Instruments Corporation | 2022-06-14 | 284 | 0 |
| K211332 | D Camera Controller | Richard Wolf Medical Instruments Corporation | 2021-10-01 | 151 | 0 |
| K203226 | TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / | Richard Wolf Medical Instruments Corporation | 2021-05-14 | 193 | 0 |
| K201897 | Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), A | Richard Wolf Medical Instruments Corporation | 2021-01-15 | 191 | 0 |
| K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, | Richard Wolf Medical Instruments Corporation | 2020-06-23 | 106 | 0 |
| K183188 | Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Se | Richard Wolf Medical Instruments Corporation | 2019-05-03 | 165 | 0 |
| K180583 | LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD | Richard Wolf Medical Instruments Corporation | 2018-06-28 | 115 | 0 |
| K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl R | Richard Wolf Medical Instruments Corporation | 2017-04-05 | 57 | 0 |
| K161204 | ENDOCAM Flex HD Camera System 5521 | Richard Wolf Medical Instruments Corporation | 2017-01-11 | 258 | 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