Medipart Jerry Alexander: FDA filings under this applicant name
FDA lists 49 510(k) clearances under the applicant name “Medipart Jerry Alexander” (first 1984, latest 1990), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| IYT | System, Rebreathing, Radionuclide | 23 | 23 |
| CAH | Filter, Bacterial, Breathing-Circuit | 8 | 8 |
| BSJ | Mask, Gas, Anesthetic | 6 | 6 |
| BYP | Mouthpiece, Breathing | 4 | 4 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 2 | 2 |
| BTK | Strap, Head, Gas Mask | 1 | 1 |
| BXJ | Clip, Nose | 1 | 1 |
| BYX | Tubing, Pressure And Accessories | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| CBL | Absorbent, Carbon-Dioxide | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (23)
- Anesthesiology (18)
- General Hospital (8)
Most recent Medipart Jerry Alexander 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896885 | DISPOSABLE RESPIRTORY KIT (MP-200) | IYT | 1990-02-26 | 80 |
| K896125 | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M | IYT | 1990-02-01 | 101 |
| K896476 | DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD | IYT | 1990-01-22 | 70 |
| K896475 | DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD | IYT | 1990-01-22 | 70 |
| K896124 | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 | IYT | 1990-01-22 | 91 |
| K894138 | MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD | CAF | 1989-09-26 | 105 |
| K893532 | RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963 | CBN | 1989-08-21 | 105 |
| K862795 | MP-070-M RADIOAEROSOL KIT | IYT | 1986-08-01 | 9 |
| K862794 | MP-070 RADIOAEROSOL KIT | IYT | 1986-08-01 | 9 |
| K862793 | MP-066-M RADIOAEROSOL KIT | IYT | 1986-08-01 | 9 |
39 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medipart Jerry Alexander.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medipart Jerry Alexander (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Medipart Jerry Alexander?
FDA lists 49 510(k) clearances under the applicant name “Medipart Jerry Alexander” (first 1984, latest 1990), across 11 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 Medipart Jerry Alexander?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medipart Jerry Alexander is 64 days.
Which FDA product codes appear under Medipart Jerry Alexander?
The most frequent FDA product codes under this applicant name are IYT (System, Rebreathing, Radionuclide, 23); CAH (Filter, Bacterial, Breathing-Circuit, 8); BSJ (Mask, Gas, Anesthetic, 6).
Next steps
- See all 49 Medipart Jerry Alexander clearances with predicates and recalls
- Run predicate analysis for product code IYT, Medipart Jerry Alexander'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.