Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Citation Medical Corp. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
232 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951941 | CITATION MULTIPLE USE DELTA SCOPE | Citation Medical Corp. | 1995-07-14 | 80 | 0 |
| K945390 | CITATION DELTA SCOPE | Citation Medical Corp. | 1995-06-23 | 232 | 0 |
| K946290 | CITATION POWER TOOL | Citation Medical Corp. | 1995-06-15 | 170 | 0 |
| K951249 | CITATION SINUSCOPE | Citation Medical Corp. | 1995-04-10 | 21 | 0 |
| K944976 | BRONCHOSCOPE,NON-RIGID | Citation Medical Corp. | 1994-12-21 | 71 | 0 |
| K940847 | ENDOSCOPIC PLANTAR FASCIA KIT | Citation Medical Corp. | 1994-10-11 | 230 | 0 |
| K941563 | THE BIOPSY TOOL | Citation Medical Corp. | 1994-09-26 | 178 | 0 |
| K924494 | CITSCOPE, BENDABLE -- MODIFICATION | Citation Medical Corp. | 1993-05-26 | 272 | 0 |
| K922144 | CITSCOPE (MODEL EXTENSIONS) | Citation Medical Corp. | 1992-08-05 | 91 | 0 |
| K921692 | INTEGRATED VIDEO SYSTEM | Citation Medical Corp. | 1992-07-01 | 84 | 0 |
| K912490 | CITATION MEDICAL SCOPE PROCEDURE PACK | Citation Medical Corp. | 1991-08-16 | 73 | 0 |
| K910587 | MINISCOPE | Citation Medical Corp. | 1991-05-13 | 90 | 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