National Medical Care, Medical Products Div., Inc.: FDA filings under this applicant name
FDA lists 62 510(k) clearances under the applicant name “National Medical Care, Medical Products Div., Inc.” (first 1985, latest 1996), across 13 product codes in 1 review panel. Median 510(k) review time under this name: 79 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 |
|---|---|---|---|
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 30 | 30 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 9 | 9 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 7 | 7 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 4 | 4 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 3 | 3 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 2 | 2 |
| FIN | Tank, Holding, Dialysis | 1 | 1 |
| FJB | Detector, Dialysate Level | 1 | 1 |
| FJG | Dialyzer, Parallel Flow | 1 | 1 |
| FJH | Dialyzer, Disposable | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent National Medical Care, Medical Products Div., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962081 | COMBILINES HEMODIALYSIS BLOOD TUBING SET | FJK | 1996-11-01 | 157 |
| K941757 | FORMALIN REUSE CART | LIF | 1996-01-22 | 654 |
| K952343 | FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER | FJI | 1995-12-22 | 217 |
| K930843 | RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 | KDJ | 1994-08-31 | 559 |
| K914790 | HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R | FJI | 1993-03-05 | 499 |
| K920797 | HEMODIALYSIS BLOOD TUBING SET | FJK | 1992-09-21 | 213 |
| K920697 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP | FJH | 1992-09-21 | 220 |
| K920693 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 | FJG | 1992-09-21 | 220 |
| K920586 | DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET | KDJ | 1992-09-21 | 224 |
| K920029 | DEXTROLYTE II CAPD TRNSFER SET | KDJ | 1992-09-21 | 262 |
52 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named National Medical Care, Medical Products Div., 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.
- National Patent Development Corp. (34 510(k)s)
- National Biological Corp. (28 510(k)s)
- National Custom Ent., Inc. (12 510(k)s)
- National Advanced Endoscopy Devices, Inc. (8 510(k)s)
- National Catheter Co. Div. Mallinckrodt (8 510(k)s)
- National Healthcare Mfg. Corp. (7 510(k)s)
- National Wire & Stamping, Inc. (5 510(k)s)
- National Health-Care Equipment, Inc. (4 510(k)s)
- National Healthcare Linen Service (4 510(k)s)
- National Medical Technology (4 510(k)s)
- National Display Systems (3 510(k)s)
- National Hearing Aid Dist., Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under National Medical Care, Medical Products Div., Inc.?
FDA lists 62 510(k) clearances under the applicant name “National Medical Care, Medical Products Div., Inc.” (first 1985, latest 1996), across 13 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by National Medical Care, Medical Products Div., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name National Medical Care, Medical Products Div., Inc. is 79 days.
Which FDA product codes appear under National Medical Care, Medical Products Div., Inc.?
The most frequent FDA product codes under this applicant name are KDJ (Set, Administration, For Peritoneal Dialysis, Disposable, 30); FJI (Dialyzer, Capillary, Hollow Fiber, 9); FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, 7).
Next steps
- See all 62 National Medical Care, Medical Products Div., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDJ, National Medical Care, Medical Products Div., 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.