Philadelphia Medical Specialties: FDA clearances and approvals
Philadelphia Medical Specialties has 6 FDA 510(k) clearances (first 1981, latest 1984), across 2 product codes in 1 review panel. Median 510(k) review time: 20 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 |
|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | 3 | 3 |
| GWN | Nystagmograph | 3 | 3 |
Review panels
- Neurology (6)
Most recent Philadelphia Medical Specialties 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K840999 | PHILLY INFANT BOLT | GWM | 1984-04-04 | 26 |
| K834148 | PHILLY BOLTS | GWN | 1984-02-10 | 86 |
| K823459 | PHILLY BOLT ADULT PROCEDURE KIT | GWN | 1982-12-22 | 34 |
| K822636 | CLASS II DEVICE FOR I.C.P. MONITORING | GWM | 1982-09-14 | 14 |
| K820151 | PHILLY INFANT BOLT | GWN | 1982-01-28 | 9 |
| K813440 | PHILLY BOLT | GWM | 1981-12-18 | 10 |
Recalls
openFDA lists no recalls under a recalling firm named Philadelphia Medical Specialties.
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 Philadelphia Medical Specialties have?
Philadelphia Medical Specialties has 6 FDA 510(k) clearances (first 1981, latest 1984), across 2 product codes in 1 review panel.
How long does FDA take to clear Philadelphia Medical Specialties's 510(k)s?
The median time from FDA receipt to decision across Philadelphia Medical Specialties's cleared 510(k)s is 20 days.
What devices does Philadelphia Medical Specialties make?
Its most frequent FDA product codes are GWM (Device, Monitoring, Intracranial Pressure, 3); GWN (Nystagmograph, 3).
Has Philadelphia Medical Specialties had device recalls?
openFDA lists no recalls under a recalling firm name matching Philadelphia Medical Specialties. Related entities may recall under other names.
Next steps
- See all 6 Philadelphia Medical Specialties clearances with predicates and recalls
- Run predicate analysis for product code GWM, Philadelphia Medical Specialties'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.