Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Capintec, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
198 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192199 | CRC PC Smart Chamber K1 | Capintec, Inc. | 2019-09-12 | 30 | 0 |
| K162394 | CRC-77tHR | Capintec, Inc. | 2017-03-08 | 194 | 0 |
| K141413 | CRC PC WITH SMART CHAMBER | Capintec, Inc. | 2014-06-27 | 29 | 0 |
| K101452 | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, C | Capintec, Inc. | 2010-08-09 | 76 | 0 |
| K071396 | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS | Capintec, Inc. | 2007-06-28 | 38 | 1 |
| K052595 | CRC 15ULTRA | Capintec, Inc. | 2005-11-08 | 48 | 0 |
| K030175 | 2 BASIC | Capintec, Inc. | 2003-04-17 | 90 | 0 |
| K020150 | CRC-15BT | Capintec, Inc. | 2002-08-02 | 198 | 0 |
| K982448 | CARDIOLIGHT | Capintec, Inc. | 1999-06-11 | 331 | 0 |
| K980402 | CAPINTEC MODEL 292 ELECTROMETER | Capintec, Inc. | 1998-04-24 | 81 | 0 |
| K946387 | CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER | Capintec, Inc. | 1995-03-30 | 125 | 0 |
| K853737 | VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) | Capintec, Inc. | 1986-02-13 | 160 | 0 |
| K823240 | CAP-RIA 16 | Capintec, Inc. | 1982-12-03 | 32 | 0 |
| K780157 | RADIATION TREATMENT PLANNING SYSTEM | Capintec, Inc. | 1978-02-13 | 14 | 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