Nanma Mfg Co., Ltd.: FDA clearances and approvals
Nanma Mfg Co., Ltd. has 9 FDA 510(k) clearances (first 2000, latest 2004), across 1 product code in 1 review panel. Median 510(k) review time: 205 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 |
|---|---|---|---|
| LKY | Device, External Penile Rigidity | 9 | 9 |
Review panels
Most recent Nanma Mfg Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041573 | NANMA VACUUM PUMP PROXZEK MODEL 2M9498S | LKY | 2004-08-25 | 72 |
| K030119 | NANMA ADJUSTABLE CONSTRICTION RING | LKY | 2003-08-06 | 205 |
| K030913 | NANMA VACUUM PUMP | LKY | 2003-06-03 | 71 |
| K013113 | MODIFICATION TO NANMA VACUUM PUMP | LKY | 2002-12-20 | 458 |
| K013051 | NANMA ADJUSTABLE CONSTRICTION RING | LKY | 2002-08-22 | 345 |
| K013053 | MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING | LKY | 2002-05-09 | 240 |
| K993909 | NANMA VACUUM PUMP | LKY | 2000-07-19 | 245 |
| K993908 | NANMA AJUSTABLE CONSTRICTION RING | LKY | 2000-01-31 | 75 |
| K993906 | NANMA NON-ADJUSTABLE CONSTRICTION RING | LKY | 2000-01-31 | 75 |
Recalls
openFDA lists no recalls under a recalling firm named Nanma Mfg Co., Ltd..
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 Nanma Mfg Co., Ltd. have?
Nanma Mfg Co., Ltd. has 9 FDA 510(k) clearances (first 2000, latest 2004), across 1 product code in 1 review panel.
How long does FDA take to clear Nanma Mfg Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Nanma Mfg Co., Ltd.'s cleared 510(k)s is 205 days.
What devices does Nanma Mfg Co., Ltd. make?
Its most frequent FDA product codes are LKY (Device, External Penile Rigidity, 9).
Has Nanma Mfg Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Nanma Mfg Co., Ltd. Related entities may recall under other names.
Next steps
- See all 9 Nanma Mfg Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LKY, Nanma Mfg Co., Ltd.'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.