Guardian Angel Products, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Guardian Angel Products, Inc.” (first 1990, latest 2003), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 234 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 |
|---|---|---|---|
| DRL | Tester, Defibrillator | 2 | 2 |
| GDF | Guide, Needle, Surgical | 2 | 2 |
| KGQ | Cream, Gloving, Surgeon'S | 1 | 1 |
Review panels
Most recent Guardian Angel Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030547 | MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE | DRL | 2003-07-11 | 141 |
| K923840 | NEEDLE-GRABBER | GDF | 1993-07-13 | 347 |
| K923835 | THE ELEVENTH FINGER | GDF | 1993-07-09 | 343 |
| K910687 | GUARDIAN GEL, SURGEON'S GLOVING CREAM | KGQ | 1991-10-11 | 234 |
| K896985 | ZAP-GUARD | DRL | 1990-07-31 | 230 |
Recalls
openFDA lists no recalls under a recalling firm named Guardian Angel Products, Inc..
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.
- Guardian Products Co., Inc. (8 510(k)s)
- Guardian Scientific, Corp. (4 510(k)s)
- Guardian Chemical (2 510(k)s)
- Guardian Group, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guardian Angel Products, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Guardian Angel Products, Inc.” (first 1990, latest 2003), across 3 product codes in 3 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 Guardian Angel Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guardian Angel Products, Inc. is 234 days.
Which FDA product codes appear under Guardian Angel Products, Inc.?
The most frequent FDA product codes under this applicant name are DRL (Tester, Defibrillator, 2); GDF (Guide, Needle, Surgical, 2); KGQ (Cream, Gloving, Surgeon'S, 1).
Next steps
- See all 5 Guardian Angel Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRL, Guardian Angel Products, 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.