National Catheter Co. Div. Mallinckrodt: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “National Catheter Co. Div. Mallinckrodt” (first 1977, latest 1981), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 27 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 2 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| GBA | Catheter, Balloon Type | 1 | 1 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 1 | 1 |
Review panels
Most recent National Catheter Co. Div. Mallinckrodt 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802918 | ANTHRON CATHETER SET | FOZ | 1981-04-21 | 153 |
| K802505 | DOUBLE LUMEN TRACHEAL TUBE | BTR | 1981-03-13 | 149 |
| K810321 | REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) | BTO | 1981-03-04 | 26 |
| K801924 | HI-LO TEMP GEN. PURPOSE TEMP. PROBE | FLL | 1980-09-09 | 28 |
| K801005 | MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) | BTR | 1980-05-23 | 25 |
| K791190 | STETHOSCOPE WITH TEMPERATURE SENSOR | BZT | 1979-07-06 | 10 |
| K781665 | TUBE, LEATHERMAN/IMBRUCE | GBA | 1978-12-15 | 78 |
| K770727 | MANIPULATOR & INJECTOR, UTERINE | KNA | 1977-04-26 | 7 |
Recalls
openFDA lists no recalls under a recalling firm named National Catheter Co. Div. Mallinckrodt.
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 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 Catheter Co. Div. Mallinckrodt?
FDA lists 8 510(k) clearances under the applicant name “National Catheter Co. Div. Mallinckrodt” (first 1977, latest 1981), across 7 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 Catheter Co. Div. Mallinckrodt?
The median time from FDA receipt to decision across 510(k)s cleared under the name National Catheter Co. Div. Mallinckrodt is 27 days.
Which FDA product codes appear under National Catheter Co. Div. Mallinckrodt?
The most frequent FDA product codes under this applicant name are BTR (Tube, Tracheal (W/Wo Connector), 2); BTO (Tube, Tracheostomy (W/Wo Connector), 1); BZT (Stethoscope, Esophageal, With Electrical Conductors, 1).
Next steps
- See all 8 National Catheter Co. Div. Mallinckrodt clearances with predicates and recalls
- Run predicate analysis for product code BTR, National Catheter Co. Div. Mallinckrodt'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.