Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intensive Technology, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
208 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922970 | INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM | Intensive Technology, Inc. | 1993-01-13 | 208 | 0 |
| K912664 | TEC ROTATING DUAL HEMOVALVE | Intensive Technology, Inc. | 1992-08-24 | 433 | 0 |
| K911869 | IVT GUIDING CATHETER | Intensive Technology, Inc. | 1991-10-16 | 173 | 0 |
| K903463 | IVT INTRODUCER SHEATH | Intensive Technology, Inc. | 1991-01-03 | 155 | 0 |
| K904003 | HEMOCHRON(R) HEPARIN RESPONSE TEST | Intensive Technology, Inc. | 1990-11-29 | 92 | 1 |
| K901767 | MODIFIED IVT PERIPHERAL ATHERECTOMY | Intensive Technology, Inc. | 1990-06-28 | 72 | 0 |
| K896403 | MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM | Intensive Technology, Inc. | 1990-03-06 | 119 | 0 |
| K895903 | IVT 0.014 GUIDE WIRE | Intensive Technology, Inc. | 1990-01-04 | 90 | 0 |
| K892209 | APTT BY HEMOCHRON(R) | Intensive Technology, Inc. | 1989-06-22 | 80 | 0 |
| K890515 | PERIPHERAL ATHERECTOMY SYSTEM | Intensive Technology, Inc. | 1989-05-23 | 111 | 0 |
| K882804 | 0.014 PERIPHERAL GUIDE WIRE | Intensive Technology, Inc. | 1988-10-28 | 113 | 0 |
| K810107 | RESPA-TROL | Intensive Technology, Inc. | 1981-01-26 | 10 | 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