Mac Lee Medical Products: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Mac Lee Medical Products” (first 1979, latest 1988), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 21 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 7 | 7 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| FCE | Enema Kit | 1 | 1 |
| FGD | Catheter, Retention, Barium Enema With Bag | 1 | 1 |
| HED | Douche Apparatus, Vaginal, Therapeutic | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
| KTC | Bath, Sitz, Nonpowered | 1 | 1 |
Review panels
- General Hospital (9)
- Gastroenterology and Urology (3)
- Obstetrics and Gynecology (1)
- Physical Medicine (1)
Most recent Mac Lee Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K872953 | DISPOSABLE I.V. ADMINISTRATION SET | FPA | 1988-01-06 | 161 |
| K872006 | DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF | FGD | 1987-11-17 | 175 |
| K870995 | SCALP VEIN SET | FPA | 1987-07-31 | 142 |
| K864781 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC | FMF | 1986-12-29 | 21 |
| K864779 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC | FMF | 1986-12-29 | 21 |
| K864778 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC | FMF | 1986-12-29 | 21 |
| K864777 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC | FMF | 1986-12-29 | 21 |
| K864783 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC | FMF | 1986-12-23 | 15 |
| K864782 | MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC | FMF | 1986-12-23 | 15 |
| K864780 | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC | FMF | 1986-12-23 | 15 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mac Lee Medical Products.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mac Lee Medical Products?
FDA lists 14 510(k) clearances under the applicant name “Mac Lee Medical Products” (first 1979, latest 1988), across 7 product codes in 4 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 Mac Lee Medical Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mac Lee Medical Products is 21 days.
Which FDA product codes appear under Mac Lee Medical Products?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 7); FPA (Set, Administration, Intravascular, 2); FCE (Enema Kit, 1).
Next steps
- See all 14 Mac Lee Medical Products clearances with predicates and recalls
- Run predicate analysis for product code FMF, Mac Lee Medical Products'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.