Guardian Products Co., Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Guardian Products Co., Inc.” (first 1977, latest 1992), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 20 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 |
|---|---|---|---|
| IKX | Aid, Transfer | 2 | 2 |
| ILS | Adaptor, Hygiene | 2 | 2 |
| IKN | Electromyograph, Diagnostic | 1 | 1 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
| IPS | Cane | 1 | 1 |
| ITJ | Walker, Mechanical | 1 | 1 |
Review panels
- Physical Medicine (7)
- Neurology (1)
Most recent Guardian Products Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915108 | FOLDING WHEELCHAIR | IOR | 1992-01-13 | 61 |
| K842650 | WALL GRAB BARS 98130-98136 | IKX | 1984-08-10 | 31 |
| K842649 | BATH TUB TRANSFER CHAIR | IKN | 1984-08-10 | 31 |
| K842651 | COMMODE CHAIR 98200 | ILS | 1984-08-07 | 28 |
| K821010 | BATHTUB TRANSFER BENCH | IKX | 1982-04-21 | 9 |
| K821009 | BATHTUB GRAB BAR | ILS | 1982-04-21 | 9 |
| K790299 | FOREARM-CANE | IPS | 1979-02-21 | 9 |
| K772049 | WALKING AID | ITJ | 1977-11-11 | 11 |
Recalls
openFDA lists no recalls under a recalling firm named Guardian Products Co., 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 Angel Products, Inc. (5 510(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 Products Co., Inc.?
FDA lists 8 510(k) clearances under the applicant name “Guardian Products Co., Inc.” (first 1977, latest 1992), across 6 product codes in 2 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 Products Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guardian Products Co., Inc. is 20 days.
Which FDA product codes appear under Guardian Products Co., Inc.?
The most frequent FDA product codes under this applicant name are IKX (Aid, Transfer, 2); ILS (Adaptor, Hygiene, 2); IKN (Electromyograph, Diagnostic, 1).
Next steps
- See all 8 Guardian Products Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code IKX, Guardian Products Co., 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.