National Healthcare Mfg. Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “National Healthcare Mfg. Corp.” (first 1996, latest 1997), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 43 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 |
|---|---|---|---|
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | 1 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 1 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 1 | 1 |
| LJH | System, Irrigation, Urological | 1 | 1 |
Review panels
- Gastroenterology and Urology (3)
- General and Plastic Surgery (2)
- Obstetrics and Gynecology (1)
- Ophthalmic (1)
Most recent National Healthcare Mfg. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972013 | NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS | KNA | 1997-08-26 | 88 |
| K971465 | NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS | HOY | 1997-06-04 | 43 |
| K971317 | NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS | KDD | 1997-05-08 | 29 |
| K962670 | NHMC IRRIGATION TRAY | LJH | 1996-08-14 | 36 |
| K962254 | NHMC URETHRAL CATHETERIZATION TRAY | FCM | 1996-07-29 | 47 |
| K960523 | NHMC DRESSING TRAY | EFQ | 1996-04-04 | 58 |
| K960566 | NHMC FOLEY CATHETERIZATION TRAY | FCM | 1996-02-29 | 20 |
Recalls
openFDA lists no recalls under a recalling firm named National Healthcare Mfg. Corp..
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 Medical Care, Medical Products Div., Inc. (62 510(k)s)
- 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 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 Healthcare Mfg. Corp.?
FDA lists 7 510(k) clearances under the applicant name “National Healthcare Mfg. Corp.” (first 1996, latest 1997), across 6 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 National Healthcare Mfg. Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name National Healthcare Mfg. Corp. is 43 days.
Which FDA product codes appear under National Healthcare Mfg. Corp.?
The most frequent FDA product codes under this applicant name are FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), 2); EFQ (Gauze/Sponge, Internal, 1); HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear), 1).
Next steps
- See all 7 National Healthcare Mfg. Corp. clearances with predicates and recalls
- Run predicate analysis for product code FCM, National Healthcare Mfg. Corp.'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.