Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Contour Fabricators of Florida, Inc. · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
295 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955685 | RNS STERILE, DISPOSABLE CT BIOPSY TRAY | Contour Fabricators of Florida, Inc. | 1996-10-04 | 295 | 0 |
| K962040 | RNS ARTHROGRAM TRAY | Contour Fabricators of Florida, Inc. | 1996-06-25 | 32 | 0 |
| K955687 | RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY | Contour Fabricators of Florida, Inc. | 1996-06-03 | 172 | 0 |
| K955689 | RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY | Contour Fabricators of Florida, Inc. | 1996-05-15 | 153 | 0 |
| K955684 | RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY | Contour Fabricators of Florida, Inc. | 1996-05-02 | 140 | 0 |
| K955679 | RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY | Contour Fabricators of Florida, Inc. | 1996-03-12 | 89 | 0 |
| K955678 | RNS STERILE DISPOSABLE PUNCTURE TRAY | Contour Fabricators of Florida, Inc. | 1996-02-21 | 69 | 0 |
| K955686 | RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY | Contour Fabricators of Florida, Inc. | 1996-02-21 | 69 | 0 |
| K955688 | RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY | Contour Fabricators of Florida, Inc. | 1996-02-21 | 69 | 0 |
| K955683 | RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY | Contour Fabricators of Florida, Inc. | 1996-02-01 | 49 | 0 |
| K952395 | REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION | Contour Fabricators of Florida, Inc. | 1995-08-15 | 85 | 0 |
| K952396 | REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTIO | Contour Fabricators of Florida, Inc. | 1995-08-15 | 85 | 0 |
| K952406 | REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W | Contour Fabricators of Florida, Inc. | 1995-08-07 | 77 | 0 |
| K952407 | REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE | Contour Fabricators of Florida, Inc. | 1995-08-07 | 77 | 0 |
| K952925 | READY NURSE SYSTEM (RNS) TRACH CARE KIT | Contour Fabricators of Florida, Inc. | 1995-07-12 | 16 | 0 |
| K934072 | CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM | Contour Fabricators of Florida, Inc. | 1994-09-08 | 384 | 0 |
| K935092 | CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM | Contour Fabricators of Florida, Inc. | 1994-06-10 | 228 | 0 |
| K933151 | CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM | Contour Fabricators of Florida, Inc. | 1993-12-13 | 167 | 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