Vanguard Biomedical Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Vanguard Biomedical Corp.” (first 1988, latest 1996), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 4 | 4 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 | 3 |
Review panels
- Clinical Chemistry (10)
Most recent Vanguard Biomedical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960733 | MINISTICK PREGNANCY TEST | LCX | 1996-05-01 | 69 |
| K960233 | MINICLINIC OVULATION PREDICTOR | CEP | 1996-04-23 | 97 |
| K930014 | PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST | JHI | 1993-03-25 | 80 |
| K914254 | HOMECLINIC ONE STEP PREGNANCY TEST | LCX | 1991-10-17 | 24 |
| K914253 | PROCLINIC ONE STEP PREGNANCY TEST | JHI | 1991-10-11 | 18 |
| K910351 | MINICLINIC OVULATION PREDICTION TEST | CEP | 1991-03-21 | 65 |
| K895560 | MODIFIED HOMECLINIC PREGNANCY TEST | LCX | 1989-11-13 | 68 |
| K894012 | MINICLINIC PREGNANCY TEST | JHI | 1989-07-25 | 49 |
| K891762 | MINICLINIC OVULATION PREDICTION TEST | CEP | 1989-07-20 | 118 |
| K883826 | HOME CLINIC PREGNANCY TEST | LCX | 1988-11-29 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Vanguard Biomedical Corp..
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 Medical Concepts, Inc. (33 510(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 Biomedical Corp.?
FDA lists 10 510(k) clearances under the applicant name “Vanguard Biomedical Corp.” (first 1988, latest 1996), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vanguard Biomedical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vanguard Biomedical Corp. is 68 days.
Which FDA product codes appear under Vanguard Biomedical Corp.?
The most frequent FDA product codes under this applicant name are LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 4); CEP (Radioimmunoassay, Luteinizing Hormone, 3); JHI (Visual, Pregnancy Hcg, Prescription Use, 3).
Next steps
- See all 10 Vanguard Biomedical Corp. clearances with predicates and recalls
- Run predicate analysis for product code LCX, Vanguard Biomedical Corp.'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.