Ascent Healthcare Solutions: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Ascent Healthcare Solutions” (first 2006, latest 2011), across 10 product codes in 5 review panels. Median 510(k) review time under this name: 120 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 |
|---|---|---|---|
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | 5 | 5 |
| NLH | Catheter, Recording, Electrode, Reprocessed | 4 | 4 |
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | 2 | 2 |
| NQG | Stabilizer, Heart, Non-Compression, Reprocessed | 2 | 2 |
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | 2 | 2 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| JOW | Sleeve, Limb, Compressible | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| NLF | Oximeter, Reprocessed | 1 | 1 |
Review panels
- Cardiovascular (9)
- Gastroenterology and Urology (5)
- General and Plastic Surgery (5)
- Anesthesiology (1)
- Orthopedic (1)
Most recent Ascent Healthcare Solutions 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111600 | REPROCESSED HAND ACTIVATE SEALER/DIVIDER | NUJ | 2011-11-15 | 160 |
| K110189 | REPROCESSED ELECTROSURGICAL INSTRUMENT | NUJ | 2011-07-18 | 175 |
| K100909 | REPROCESSED COMPRESSION SLEEVES | JOW | 2010-07-23 | 113 |
| K100254 | REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER | NLH | 2010-05-28 | 120 |
| K100537 | REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE | NLQ | 2010-05-12 | 76 |
| K100080 | REPROCESSED TROCARS, MODEL B5LT AND CB5LT | NLM | 2010-03-19 | 66 |
| K093702 | REPROCESSED ULTRASONIC COAGULATING SHEARS | NLQ | 2010-03-04 | 93 |
| K092425 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 | OWQ | 2009-10-21 | 75 |
| K090323 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | 2009-04-01 | 51 |
| K082023 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | NLH | 2008-09-16 | 62 |
11 earlier clearances. See the full list in Caduvo.
Recalls
41 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2010-06-23.
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.
- Ascent Consumer Products, Inc. (1 510(k)s)
- Ascent Heatlhcare Solutions (1 510(k)s)
- Ascent Medical, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ascent Healthcare Solutions?
FDA lists 21 510(k) clearances under the applicant name “Ascent Healthcare Solutions” (first 2006, latest 2011), across 10 product codes in 5 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 Ascent Healthcare Solutions?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ascent Healthcare Solutions is 120 days.
Which FDA product codes appear under Ascent Healthcare Solutions?
The most frequent FDA product codes under this applicant name are NLM (Laparoscope, General & Plastic Surgery, Reprocessed, 5); NLH (Catheter, Recording, Electrode, Reprocessed, 4); NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments, 2).
Next steps
- See all 21 Ascent Healthcare Solutions clearances with predicates and recalls
- Run predicate analysis for product code NLM, Ascent Healthcare Solutions'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.