Custom Ultrasonics: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Custom Ultrasonics” (first 1984, latest 2020), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 210 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 | 1 | 186 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 270 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 860 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Custom Ultrasonics took a median 565 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FEB | Accessories, Cleaning, For Endoscope | 4 | 4 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | 1 | 1 |
| NVE | Washer, Cleaner, Automated, Endoscope | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Custom Ultrasonics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173590 | System 83 Plus Washer/Disinfector | FEB | 2020-03-30 | 860 |
| K162120 | Scope-Assist Flushing Sink | FEB | 2017-04-28 | 270 |
| K122172 | SYSTEM 83 PLUS | FEB | 2013-01-25 | 186 |
| K061430 | SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR | FEB | 2007-01-12 | 234 |
| K983017 | MODIFICATION TO SYSTEM 83 PLUS | NVE | 1998-09-22 | 25 |
| K842754 | CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 | FLG | 1984-11-28 | 135 |
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2016-05-06.
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.
- Custom Pack Reliability (21 510(k)s)
- Custom Medical Products, Ltd. (14 510(k)s)
- Custom Spine, Inc. (14 510(k)s)
- Custom Services Intl., Inc. (9 510(k)s)
- Custom Orthopaedic Solutions, Inc. (8 510(k)s)
- Custom Optical Frames, Inc. (4 510(k)s)
- Custom Surgical Products, Inc. (4 510(k)s)
- Custom Medical, Inc. (3 510(k)s)
- Custom Medical Devices Intl., Inc. (3 510(k)s)
- Custom Cardio Components (2 510(k)s)
- Custom Medical Plastics, Inc. (2 510(k)s)
- Custom Assemblies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Custom Ultrasonics?
FDA lists 6 510(k) clearances under the applicant name “Custom Ultrasonics” (first 1984, latest 2020), across 3 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 Custom Ultrasonics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Custom Ultrasonics is 210 days.
Which FDA product codes appear under Custom Ultrasonics?
The most frequent FDA product codes under this applicant name are FEB (Accessories, Cleaning, For Endoscope, 4); FLG (Cleaner, Ultrasonic, Medical Instrument, 1); NVE (Washer, Cleaner, Automated, Endoscope, 1).
Next steps
- See all 6 Custom Ultrasonics clearances with predicates and recalls
- Run predicate analysis for product code FEB, Custom Ultrasonics'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.