Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FGA — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
173 daysmedian FDA review time
267 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232370 | Percutaneous Nephroscope System | Karl Storz SE & CO. KG | 2024-05-01 | 267 | 8 |
| K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Se | Schoelly Fiberoptic GmbH | 2016-02-09 | 267 | 0 |
| K072594 | GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE | Gyrus Acmi, Inc. | 2007-12-13 | 90 | 0 |
| K994223 | NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHM | Richard Wolf Medical Instruments Corp. | 2000-06-05 | 173 | 0 |
| K950433 | KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDUR | KARL STORZ Endoscopy-America, Inc. | 1995-03-15 | 41 | 0 |
| K940594 | KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE | KARL STORZ Endoscopy-America, Inc. | 1994-09-09 | 212 | 0 |
| K922826 | FLEXIBLE FIBER OPTIC ENDOSCOPE | Optimed Technologies, Inc. | 1993-02-19 | 253 | 1 |
| K853486 | OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE | Olympus Corp. | 1985-09-12 | 23 | 0 |
| K791182 | ACMI RIGI-FLEX NEPHORSCOPE | American Cystocope Makers, Inc. | 1979-07-30 | 35 | 0 |
| K770729 | PYELOSCOPE SYSTEM | Richard Wolf Medical Instruments Corp. | 1977-04-28 | 8 | 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