White Knight Healthcare: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “White Knight Healthcare” (first 1994, latest 2001), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 140 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 |
|---|---|---|---|
| FXX | Mask, Surgical | 4 | 4 |
| FYA | Gown, Surgical | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| LYU | Accessory, Surgical Apparel | 1 | 1 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | 1 | 1 |
Review panels
Most recent White Knight Healthcare 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001892 | WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) | FXX | 2001-04-03 | 286 |
| K001997 | WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) | FXX | 2001-04-02 | 276 |
| K001893 | WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS) | FXX | 2001-04-02 | 285 |
| K951984 | WHITE KNIGHT SURGEON'S VEST | FYA | 1995-07-25 | 89 |
| K943809 | MONOGARD FACE SHIELD | LYU | 1994-11-28 | 116 |
| K942577 | SURGICAL TIP CLEANER | GEI | 1994-07-26 | 56 |
| K942576 | CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE | OCT | 1994-07-05 | 35 |
| K934969 | DUALGARD FACE SHIELD | FXX | 1994-03-28 | 165 |
Recalls
openFDA lists no recalls under a recalling firm named White Knight Healthcare.
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.
- White Peaks Dental Systems GmbH & Co. KG (3 510(k)s)
- White River Concepts (3 510(k)s)
- White River (Tm) (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under White Knight Healthcare?
FDA lists 8 510(k) clearances under the applicant name “White Knight Healthcare” (first 1994, latest 2001), across 5 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 White Knight Healthcare?
The median time from FDA receipt to decision across 510(k)s cleared under the name White Knight Healthcare is 140 days.
Which FDA product codes appear under White Knight Healthcare?
The most frequent FDA product codes under this applicant name are FXX (Mask, Surgical, 4); FYA (Gown, Surgical, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 8 White Knight Healthcare clearances with predicates and recalls
- Run predicate analysis for product code FXX, White Knight Healthcare'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.