Manan Medical Products, Inc.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Manan Medical Products, Inc.” (first 1988, latest 2005), across 19 product codes in 6 review panels. Median 510(k) review time under this name: 84 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 | 10 | 10 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 4 | 4 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 3 | 3 |
| GAA | Needle, Aspiration And Injection, Disposable | 3 | 3 |
| LJE | Catheter, Nephrostomy | 3 | 3 |
| EXF | Bag, Bile Collecting | 2 | 2 |
| IWJ | System, Applicator, Radionuclide, Manual | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DWO | Needle, Biopsy, Cardiovascular | 1 | 1 |
| FCG | Biopsy Needle | 1 | 1 |
Plus 9 more product codes.
Review panels
- General and Plastic Surgery (16)
- Gastroenterology and Urology (11)
- Anesthesiology (4)
- General Hospital (4)
- Radiology (3)
- Cardiovascular (1)
Most recent Manan Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052802 | MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE | KNW | 2005-11-01 | 29 |
| K011209 | MANAN SPRITACRE SPINAL NEEDLES | BSP | 2001-06-26 | 68 |
| K983620 | MANAN SPINAL NEEDLES | BSP | 1999-01-08 | 85 |
| K980536 | EPIDURAL NEEDLE | BSP | 1998-07-31 | 170 |
| K981386 | MANAN BLUNT NEEDLE | FPA | 1998-06-29 | 74 |
| K980211 | MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES | KNW | 1998-02-06 | 16 |
| K974446 | MANAN AUTOMATIC CUTTING NEEDLE | KNW | 1998-01-08 | 44 |
| K962977 | MRI COMPATIBLE BIOPSY NEEDLES | KNW | 1997-10-09 | 435 |
| K963767 | MANAN V.S. ACCESS NEEDLE/SET | FGE | 1997-05-16 | 239 |
| K961986 | MANAN D BAG | EXF | 1997-03-13 | 296 |
29 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2005-05-03.
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 Manufacturing Co., Inc. (20 510(k)s)
- Manan Medical Devices (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Manan Medical Products, Inc.?
FDA lists 39 510(k) clearances under the applicant name “Manan Medical Products, Inc.” (first 1988, latest 2005), across 19 product codes in 6 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 Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Manan Medical Products, Inc. is 84 days.
Which FDA product codes appear under Manan Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are KNW (Instrument, Biopsy, 10); BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 4); FGE (Stents, Drains And Dilators For The Biliary Ducts, 3).
Next steps
- See all 39 Manan Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNW, Manan Medical Products, 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, 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.