National Custom Ent., Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “National Custom Ent., Inc.” (first 1993, latest 2001), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 3 | 3 |
| MRZ | Accessories, Pump, Infusion | 3 | 3 |
| FCO | Box, Battery, Rechargeable | 2 | 2 |
| DRK | Dc-Defibrillator, High Energy, (Including Paddles) | 1 | 1 |
| ERA | Otoscope | 1 | 1 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
Review panels
Most recent National Custom Ent., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012264 | MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC | DPS | 2001-10-10 | 84 |
| K012263 | MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 | DPS | 2001-10-10 | 84 |
| K012266 | SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 | MRZ | 2001-09-12 | 56 |
| K012262 | BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC | MRZ | 2001-09-12 | 56 |
| K012259 | MEDFUSION 2001 & 2010, MODEL N7215IWC | MRZ | 2001-09-12 | 56 |
| K012229 | SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC | FMT | 2001-09-10 | 56 |
| K943680 | NCE REPLACEMENT BATTERIES | FCO | 1994-11-04 | 101 |
| K943632 | REPLACEMENT BATTERIES | FCO | 1994-11-04 | 101 |
| K942629 | NCE REPLACEMENT BATTERIES | DPS | 1994-08-18 | 76 |
| K941995 | NCE REPLACEMENT BATTERIES | LDD | 1994-07-26 | 92 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named National Custom Ent., 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under National Custom Ent., Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRZ)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via FCO)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRZ)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via MRZ)
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 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 Custom Ent., Inc.?
FDA lists 12 510(k) clearances under the applicant name “National Custom Ent., Inc.” (first 1993, latest 2001), 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 Custom Ent., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name National Custom Ent., Inc. is 80 days.
Which FDA product codes appear under National Custom Ent., Inc.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 3); MRZ (Accessories, Pump, Infusion, 3); FCO (Box, Battery, Rechargeable, 2).
Next steps
- See all 12 National Custom Ent., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, National Custom Ent., 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.