N.M. Beale Co., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “N.M. Beale Co., Inc.” (first 1990, latest 2011), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 165 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 |
|---|---|---|---|
| CCT | Applicator (Laryngo-Tracheal), Topical Anesthesia | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 | 1 |
| ODC | Endoscope Channel Accessory | 1 | 1 |
Review panels
Most recent N.M. Beale Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093584 | EZ-MISTER | CCT | 2011-03-04 | 470 |
| K093329 | SCOPE INTRODUCER MODEL 7400 | ODC | 2010-02-16 | 113 |
| K071579 | PEF TUBE | KNT | 2007-11-20 | 165 |
| K992178 | BALLOON FOR ULTRASONIC ENDOSCOPES | ITX | 2000-05-12 | 319 |
| K903834 | N. M. BEALE COMPANY VU-THRU WATER BOTTLE | OCX | 1990-09-24 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named N.M. Beale Co., 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under N.M. Beale Co., Inc.?
FDA lists 5 510(k) clearances under the applicant name “N.M. Beale Co., Inc.” (first 1990, latest 2011), across 5 product codes in 3 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 N.M. Beale Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name N.M. Beale Co., Inc. is 165 days.
Which FDA product codes appear under N.M. Beale Co., Inc.?
The most frequent FDA product codes under this applicant name are CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia, 1); ITX (Transducer, Ultrasonic, Diagnostic, 1); KNT (Tubes, Gastrointestinal (And Accessories), 1).
Next steps
- See all 5 N.M. Beale Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code CCT, N.M. Beale Co., 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.