Vanguard Medical Concepts, Inc.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Vanguard Medical Concepts, Inc.” (first 1991, latest 2005), across 18 product codes in 7 review panels. Median 510(k) review time under this name: 92 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NLH | Catheter, Recording, Electrode, Reprocessed | 9 | 9 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| NLF | Oximeter, Reprocessed | 2 | 2 |
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | 2 | 2 |
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | 2 | 2 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| FZP | Clip, Implantable | 1 | 1 |
| GDW | Staple, Implantable | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
Plus 8 more product codes.
Review panels
- Cardiovascular (13)
- General and Plastic Surgery (7)
- Orthopedic (5)
- Gastroenterology and Urology (4)
- Anesthesiology (2)
- General Hospital (1)
- Ophthalmic (1)
Most recent Vanguard Medical Concepts, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053051 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | KTT | 2005-12-22 | 55 |
| K051616 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | KTT | 2005-09-06 | 81 |
| K051180 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | KTT | 2005-07-22 | 74 |
| K051043 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | NLH | 2005-06-06 | 42 |
| K050763 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | NLH | 2005-06-01 | 69 |
| K043198 | VANGUARD REPROCESSED ARTHROSCOPIC WANDS | NUJ | 2005-05-27 | 190 |
| K043253 | VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS | NLM | 2005-04-08 | 135 |
| K043594 | VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES | NLM | 2005-03-31 | 92 |
| K043315 | VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL | NLQ | 2005-03-22 | 111 |
| K043225 | VANGUARD REPROCESSED ULTRASONIC SCALPEL | NLQ | 2005-03-22 | 120 |
23 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-03-17.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Vanguard Biomedical Corp. (10 510(k)s)
- Vanguard Diagnostic Systems (2 510(k)s)
- Vanguard Container Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vanguard Medical Concepts, Inc.?
FDA lists 33 510(k) clearances under the applicant name “Vanguard Medical Concepts, Inc.” (first 1991, latest 2005), across 18 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vanguard Medical Concepts, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vanguard Medical Concepts, Inc. is 92 days.
Which FDA product codes appear under Vanguard Medical Concepts, Inc.?
The most frequent FDA product codes under this applicant name are NLH (Catheter, Recording, Electrode, Reprocessed, 9); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2).
Next steps
- See all 33 Vanguard Medical Concepts, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NLH, Vanguard Medical Concepts, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.