Pedia Pals, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Pedia Pals, Inc.” (first 1991, latest 1995), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 188 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 |
|---|---|---|---|
| DXQ | Blood Pressure Cuff | 3 | 3 |
| ERA | Otoscope | 3 | 3 |
| EPY | Speculum, Ent | 1 | 1 |
Review panels
Most recent Pedia Pals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951041 | BLOOD PRESSURE CUFF 3 | DXQ | 1995-10-31 | 239 |
| K951040 | BLOOD PRESSURE CUFF 2 | DXQ | 1995-10-31 | 239 |
| K951039 | BLOOD PRESSURE CUFF 1 | DXQ | 1995-10-31 | 239 |
| K951050 | SPECULUM, ENT (S3) | ERA | 1995-04-17 | 42 |
| K951049 | SPECULUM, ENT (S3) | ERA | 1995-04-17 | 42 |
| K950086 | PEDIA PALS, INCORPORATED | EPY | 1995-02-07 | 28 |
| K911650 | PEDIA PALS | ERA | 1991-10-17 | 188 |
Recalls
openFDA lists no recalls under a recalling firm named Pedia Pals, 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.
- Pedia, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pedia Pals, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Pedia Pals, Inc.” (first 1991, latest 1995), 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 Pedia Pals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pedia Pals, Inc. is 188 days.
Which FDA product codes appear under Pedia Pals, Inc.?
The most frequent FDA product codes under this applicant name are DXQ (Blood Pressure Cuff, 3); ERA (Otoscope, 3); EPY (Speculum, Ent, 1).
Next steps
- See all 7 Pedia Pals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXQ, Pedia Pals, 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.