Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vanguard Medical Concepts, Inc. · Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
351 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053051 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | Vanguard Medical Concepts, Inc. | 2005-12-22 | 55 | 0 |
| K051616 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | Vanguard Medical Concepts, Inc. | 2005-09-06 | 81 | 0 |
| K051180 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | Vanguard Medical Concepts, Inc. | 2005-07-22 | 74 | 0 |
| K051043 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2005-06-06 | 42 | 0 |
| K050763 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2005-06-01 | 69 | 0 |
| K043198 | VANGUARD REPROCESSED ARTHROSCOPIC WANDS | Vanguard Medical Concepts, Inc. | 2005-05-27 | 190 | 1 |
| K043253 | VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS | Vanguard Medical Concepts, Inc. | 2005-04-08 | 135 | 1 |
| K043594 | VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCA | Vanguard Medical Concepts, Inc. | 2005-03-31 | 92 | 1 |
| K043315 | VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL | Vanguard Medical Concepts, Inc. | 2005-03-22 | 111 | 0 |
| K043225 | VANGUARD REPROCESSED ULTRASONIC SCALPEL | Vanguard Medical Concepts, Inc. | 2005-03-22 | 120 | 0 |
| K040751 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2005-03-10 | 351 | 0 |
| K042074 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2005-03-09 | 219 | 0 |
| K042594 | VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS | Vanguard Medical Concepts, Inc. | 2005-01-25 | 124 | 0 |
| K042316 | VANGUARD REPROCESSED PULSE OXIMETER SENSORS | Vanguard Medical Concepts, Inc. | 2005-01-06 | 133 | 0 |
| K031687 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | Vanguard Medical Concepts, Inc. | 2004-04-30 | 333 | 0 |
| K032973 | REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS | Vanguard Medical Concepts, Inc. | 2003-12-18 | 85 | 0 |
| K032980 | AMI REPROCESSED MULTIPLE CLIP APPLIERS | Vanguard Medical Concepts, Inc. | 2003-12-18 | 85 | 0 |
| K030114 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2003-03-21 | 67 | 0 |
| K030005 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER A | Vanguard Medical Concepts, Inc. | 2003-03-18 | 75 | 0 |
| K023180 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2002-12-12 | 79 | 0 |
| K022316 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2002-10-10 | 85 | 0 |
| K012344 | VANGUARD REPROCESSED PULSE OXIMETER SENSORS | Vanguard Medical Concepts, Inc. | 2002-10-04 | 437 | 3 |
| K012687 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2002-08-01 | 352 | 0 |
| K012688 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2002-07-31 | 351 | 0 |
| K012480 | VANGUARD REPROCESSED INFLATION DEVICES | Vanguard Medical Concepts, Inc. | 2002-01-22 | 173 | 0 |
| K011832 | VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE | Vanguard Medical Concepts, Inc. | 2001-12-21 | 192 | 1 |
| K012698 | VANGUARD REPROCESSED PHACOEMULSIFICATION | Vanguard Medical Concepts, Inc. | 2001-11-09 | 87 | 0 |
| K012700 | VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS | Vanguard Medical Concepts, Inc. | 2001-11-07 | 85 | 0 |
| K012695 | VANGUARD REPROCESSED ARTHROSCOPIC WANDS | Vanguard Medical Concepts, Inc. | 2001-10-30 | 77 | 5 |
| K012403 | VANGUARD REPROCESSED COMPRESSION GARMENT | Vanguard Medical Concepts, Inc. | 2001-10-17 | 79 | 5 |
| K012346 | VANGUARD REPROCESSED ARTHROSCOPIC BLADES | Vanguard Medical Concepts, Inc. | 2001-10-16 | 84 | 0 |
| K011800 | VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS | Vanguard Medical Concepts, Inc. | 2001-09-27 | 111 | 0 |
| K911565 | CUSTOM PROCEDURE TRAY | Vanguard Medical Concepts, Inc. | 1991-08-09 | 122 | 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