Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Tecnol Medical Products, Inc. · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
353 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974068 | PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULA | Tecnol Medical Products, Inc. | 1997-12-22 | 55 | 1 |
| K970448 | PCM 2000; ISOLAIR APR MODEL 2735 | Tecnol Medical Products, Inc. | 1997-04-30 | 83 | 0 |
| K963552 | QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350) | Tecnol Medical Products, Inc. | 1996-11-22 | 78 | 0 |
| K963559 | WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010) | Tecnol Medical Products, Inc. | 1996-11-22 | 78 | 0 |
| K963564 | PERSONAL LIMB HOLDER (24444-200,300,24444-KIT) | Tecnol Medical Products, Inc. | 1996-11-22 | 78 | 0 |
| K963554 | 24448-010 SECURE-ALL FINGER CONTROL MITT | Tecnol Medical Products, Inc. | 1996-11-21 | 77 | 0 |
| K963556 | SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020, | Tecnol Medical Products, Inc. | 1996-11-21 | 77 | 0 |
| K963557 | SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453- | Tecnol Medical Products, Inc. | 1996-11-21 | 77 | 0 |
| K963561 | ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030, | Tecnol Medical Products, Inc. | 1996-11-21 | 77 | 0 |
| K963563 | ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL( | Tecnol Medical Products, Inc. | 1996-11-21 | 77 | 0 |
| K963773 | 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY | Tecnol Medical Products, Inc. | 1996-11-21 | 63 | 0 |
| K955575 | TECNOL HYDROGEL WOUND DRESSING | Tecnol Medical Products, Inc. | 1996-01-17 | 41 | 0 |
| K954243 | TECNOL SALINE WET DRESSING | Tecnol Medical Products, Inc. | 1995-11-29 | 79 | 0 |
| K954033 | TECNOL ISLAND WOUND DRESSING | Tecnol Medical Products, Inc. | 1995-09-22 | 25 | 0 |
| K952504 | TECNOL TRANSPARENT WOUND DRESSING | Tecnol Medical Products, Inc. | 1995-07-26 | 57 | 0 |
| K932834 | TECNOL PCM 2000 | Tecnol Medical Products, Inc. | 1994-05-03 | 327 | 0 |
| K932137 | FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR | Tecnol Medical Products, Inc. | 1994-04-15 | 353 | 0 |
| K934842 | TECNOL SPLASHGUARD | Tecnol Medical Products, Inc. | 1994-03-09 | 152 | 0 |
| K915817 | TECNOL FLUIDSHIELD INFECTION CONTROL MASK | Tecnol Medical Products, Inc. | 1993-01-27 | 394 | 0 |
| K920162 | TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK | Tecnol Medical Products, Inc. | 1993-01-27 | 379 | 0 |
| K920203 | TECNOL INFECTION CONTROL MASK | Tecnol Medical Products, Inc. | 1992-10-05 | 263 | 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