National Biological Corp.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under 2 spellings of the applicant name “National Biological Corp.” (first 1977, latest 2015), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 65 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 | 1 | 98 |
| 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 |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | 27 | 27 |
| KGL | Cabinet, Phototherapy (Puva) | 1 | 1 |
Review panels
Most recent National Biological Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150912 | Houva-NET Control System | FTC | 2015-07-10 | 98 |
| K070934 | PANOSOL II TRU-BLU, MODEL UBL-417 | FTC | 2007-05-22 | 49 |
| K041212 | HOUVA 3 PHOTOTHERAPY SYSTEM | FTC | 2004-06-09 | 30 |
| K982082 | HANDISOL WOUND HEALING | FTC | 1998-10-28 | 135 |
| K934808 | UVISOL AND UVISOL II | FTC | 1993-12-16 | 70 |
| K924969 | PHOTOTHERAPY TIMER | FTC | 1993-02-23 | 146 |
| K924077 | HANDISOL | FTC | 1992-11-20 | 100 |
| K904428 | PANOSOL II UAB-228 | FTC | 1990-12-24 | 88 |
| K904427 | PANOSOL II UVB-206 | FTC | 1990-12-24 | 88 |
| K904426 | PANOSOL II UVA-218 | FTC | 1990-12-24 | 88 |
18 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2017-01-27.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- National Biological Corp. (27)
- National Biological Corporation (1)
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 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 Biological Corp.?
FDA lists 28 510(k) clearances under 2 spellings of the applicant name “National Biological Corp.” (first 1977, latest 2015), across 2 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 Biological Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name National Biological Corp. is 65 days.
Which FDA product codes appear under National Biological Corp.?
The most frequent FDA product codes under this applicant name are FTC (Light, Ultraviolet, Dermatological, 27); KGL (Cabinet, Phototherapy (Puva), 1).
Next steps
- See all 28 National Biological Corp. clearances with predicates and recalls
- Run predicate analysis for product code FTC, National Biological 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 (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.