Pfizer Medical Systems, Inc.: FDA clearances and approvals
Pfizer Medical Systems, Inc. has 12 FDA 510(k) clearances (first 1977, latest 1981), across 6 product codes in 3 review panels. Median 510(k) review time: 45 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 | 4 |
| JAK | System, X-Ray, Tomography, Computed | 4 | 4 |
| DXK | Echocardiograph | 1 | 1 |
| JAD | System, Therapeutic, X-Ray | 1 | 1 |
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | 1 | 1 |
| KPQ | System, Simulation, Radiation Therapy | 1 | 1 |
Review panels
- Radiology (10)
- Cardiovascular (1)
- Orthopedic (1)
Most recent Pfizer Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K803032 | PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL. | KPQ | 1981-01-22 | 52 |
| K802532 | PFIZONIC 300 ULTRASOUND SCANNER | IYO | 1980-12-18 | 63 |
| K802531 | PFIZONIC 200 ULTRASOUND SCANNER | IYO | 1980-12-18 | 63 |
| K802530 | PFIZONIC 250 ULTRASOUND SCANNER | IYO | 1980-12-18 | 63 |
| K802529 | PFIZONIC 100 ULTRASOUND SCANNER | DXK | 1980-12-18 | 63 |
| K802528 | PFIZONIC 150 ULTRASOUND SCANNER | IYO | 1980-12-18 | 63 |
| K801446 | PFIZER PZ-CT SCANNER | JAK | 1980-07-28 | 38 |
| K800501 | PFIZER/AS&E 0450 LOCALIZER | JDX | 1980-04-10 | 37 |
| K781752 | SCANNER, CT 0450 | JAK | 1978-11-03 | 16 |
| K780278 | RADIATION THERAPY TREAT. PLAN. SYS. | JAD | 1978-03-02 | 13 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pfizer Medical Systems, 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 Pfizer Medical Systems, Inc. have?
Pfizer Medical Systems, Inc. has 12 FDA 510(k) clearances (first 1977, latest 1981), across 6 product codes in 3 review panels.
How long does FDA take to clear Pfizer Medical Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Pfizer Medical Systems, Inc.'s cleared 510(k)s is 45 days.
What devices does Pfizer Medical Systems, Inc. make?
Its most frequent FDA product codes are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 4); JAK (System, X-Ray, Tomography, Computed, 4); DXK (Echocardiograph, 1).
Has Pfizer Medical Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pfizer Medical Systems, Inc. Related entities may recall under other names.
Next steps
- See all 12 Pfizer Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Pfizer Medical Systems, 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.