Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endocare, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
168 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101333 | CRYOCARE CS SURGICAL SYSTEM | Endocare, Inc. | 2010-06-14 | 33 | 2 |
| K062175 | CRYOCARE CN2 SYSTEM | Endocare, Inc. | 2006-08-28 | 28 | 0 |
| K060279 | CRYOCARE CS SURGICAL SYSTEM | Endocare, Inc. | 2006-02-28 | 26 | 3 |
| K050347 | MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM | Endocare, Inc. | 2005-02-25 | 14 | 0 |
| K032333 | CRYOCARE CS SURGICAL SYSTEM | Endocare, Inc. | 2003-08-12 | 14 | 0 |
| K023757 | CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 | Endocare, Inc. | 2002-12-05 | 27 | 2 |
| K021010 | MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE | Endocare, Inc. | 2002-06-06 | 69 | 0 |
| K020082 | ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAI | Endocare, Inc. | 2002-02-05 | 26 | 0 |
| K011074 | CRYOCARE SURGICAL SYSTEM | Endocare, Inc. | 2002-01-25 | 291 | 2 |
| K003811 | CRYOCARE SURGICAL SYSTEM | Endocare, Inc. | 2001-10-11 | 304 | 0 |
| K011040 | CRYOCARE CARDIAC SURGICAL SYSTEM | Endocare, Inc. | 2001-06-15 | 71 | 0 |
| K003528 | SANARUS CORE TISSUE BIOPSY SYSTEM | Endocare, Inc. | 2001-05-03 | 168 | 0 |
| K010339 | ENDOCARE PERCUTANEOUS ACCESS SET | Endocare, Inc. | 2001-03-07 | 30 | 0 |
| K002615 | SURGICAL SYSTEM WITH CRYOGUIDE | Endocare, Inc. | 2000-11-13 | 83 | 0 |
| K002396 | ENDOCARE PERCUTANEOUS ACCESS SET | Endocare, Inc. | 2000-10-13 | 67 | 0 |
| K980110 | ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM | Endocare, Inc. | 1998-04-10 | 88 | 0 |
| K973686 | ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM | Endocare, Inc. | 1997-12-22 | 87 | 0 |
| K965118 | ENDOCARE MONOPOLAR ELECTRODE | Endocare, Inc. | 1997-02-25 | 67 | 0 |
| K965243 | ENDOCARE ELECTROSURGICAL ELECTRODE | Endocare, Inc. | 1997-02-25 | 64 | 0 |
| K963970 | ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTE | Endocare, Inc. | 1997-02-25 | 145 | 0 |
| K963826 | ENDOCARE CRYCARE CRYOSURGICAL SYSTEM | Endocare, Inc. | 1996-12-18 | 84 | 0 |
| K961365 | ENDOCARE ELECTORNIC THERMOMETER SYSTEM | Endocare, Inc. | 1996-08-15 | 128 | 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