Manan Manufacturing Co., Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Manan Manufacturing Co., Inc.” (first 1985, latest 1987), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | 7 | 7 |
| DWS | Instruments, Surgical, Cardiovascular | 3 | 3 |
| GAA | Needle, Aspiration And Injection, Disposable | 3 | 3 |
| FCH | Tray, Biopsy, Without Biopsy Instruments | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| GCB | Needle, Catheter | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (11)
- Cardiovascular (3)
- Gastroenterology and Urology (1)
- General Hospital (1)
Most recent Manan Manufacturing Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873208 | MANAN TURNER STYLE NEEDLE | KNW | 1987-08-25 | 11 |
| K864405 | MANAN CONTRAST MEDIA ADMINISTRATION SET | FPA | 1986-12-18 | 38 |
| K863848 | MANAN BREST TUMOR LOCALIZATION NEEDLE | GAA | 1986-10-14 | 14 |
| K852501 | MYELOGRAM PROCEDURE TRAY | — | 1985-07-11 | 29 |
| K852018 | ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR | — | 1985-07-11 | 64 |
| K851834 | MANAN GWI GUIDE WIRE INTRODUCER | DWS | 1985-07-11 | 76 |
| K851833 | MANAN SELDINGER NEEDLE | DWS | 1985-07-11 | 76 |
| K851832 | NAMAN POTTS COURNAND NEEDLE | DWS | 1985-07-11 | 76 |
| K852428 | MANAN EPIDURAL NEEDLE | GCB | 1985-06-27 | 20 |
| K852427 | MANAN SPINAL NEEDLE | GAA | 1985-06-27 | 20 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Manan Manufacturing Co., 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.
- Manan Medical Products, Inc. (39 510(k)s)
- Manan Medical Devices (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Manan Manufacturing Co., Inc.?
FDA lists 20 510(k) clearances under the applicant name “Manan Manufacturing Co., Inc.” (first 1985, latest 1987), 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 Manan Manufacturing Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Manan Manufacturing Co., Inc. is 32 days.
Which FDA product codes appear under Manan Manufacturing Co., Inc.?
The most frequent FDA product codes under this applicant name are KNW (Instrument, Biopsy, 7); DWS (Instruments, Surgical, Cardiovascular, 3); GAA (Needle, Aspiration And Injection, Disposable, 3).
Next steps
- See all 20 Manan Manufacturing Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNW, Manan Manufacturing Co., 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.