Protectaide, Inc.: FDA clearances and approvals
Protectaide, Inc. has 11 FDA 510(k) clearances (first 1994, latest 1994), across 2 product codes in 2 review panels. Median 510(k) review time: 146 days.
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 | 7 | 7 |
| CBP | Valve, Non-Rebreathing | 4 | 4 |
Review panels
- General Hospital (7)
- Anesthesiology (4)
Most recent Protectaide, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942469 | PROTECTAIDE CPR PROTECTION PACK | CBP | 1994-10-31 | 159 |
| K942468 | PROTECTAIDE CPR PROTECTION PACK NO. 22100 | CBP | 1994-10-31 | 159 |
| K942476 | PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069 | FXX | 1994-10-18 | 146 |
| K942475 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 12351 | FXX | 1994-10-18 | 146 |
| K942474 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000 | FXX | 1994-10-18 | 146 |
| K942473 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 24592 | FXX | 1994-10-18 | 146 |
| K942472 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 26123 | FXX | 1994-10-18 | 146 |
| K942471 | PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. 29777 | FXX | 1994-10-18 | 146 |
| K942470 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 08315 | FXX | 1994-10-18 | 146 |
| K942467 | PROTECTAIDE AVIATOR CPR PROTECTION PACK NO. 31000 | CBP | 1994-10-06 | 134 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Protectaide, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Protectaide, Inc. have?
Protectaide, Inc. has 11 FDA 510(k) clearances (first 1994, latest 1994), across 2 product codes in 2 review panels.
How long does FDA take to clear Protectaide, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Protectaide, Inc.'s cleared 510(k)s is 146 days.
What devices does Protectaide, Inc. make?
Its most frequent FDA product codes are FXX (Mask, Surgical, 7); CBP (Valve, Non-Rebreathing, 4).
Has Protectaide, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Protectaide, Inc. Related entities may recall under other names.
Next steps
- See all 11 Protectaide, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FXX, Protectaide, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.