510(k) Report

FDA applicant

Ascent Healthcare Solutions

Phoenix, AZ21 decisions2006–201135 recalls

FDA records 21 decisions for Ascent Healthcare Solutions (Phoenix, AZ) from 2006 to 2011: 21 510(k) clearances. Most are in product codes NLM (Laparoscope, General & Plastic Surgery…) and NLH (Catheter, Recording, Electrode, Reprocessed). Its devices cite 48 predicates, 1 of them its own earlier devices. 35 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Ascent Healthcare Solutions’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2007: 72008: 32009: 22010: 52011: 2
2007high 7 (2007) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

26in 2026

2008: 12015: 42016: 12018: 22023: 12026 (partial year): 26
2007high 26 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ascent Healthcare Solutions by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NLMLaparoscope, General & Plastic Surgery, Reprocessed5decisions
  • NLHCatheter, Recording, Electrode, Reprocessed4decisions
  • NQGStabilizer, Heart, Non-Compression, Reprocessed2decisions
  • OWQReprocessed Intravascular Ultrasound Catheter2decisions
  • NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed2decisions
  • NLQSingle-Use Reprocessed Ultrasonic Surgical Instruments2decisions

Also: NLF (1), KTT (1), JOW (1), GEI (1).

Whose devices does it build on?

Its devices cite 48 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K062497Reprocessed TrocarsAscent Healthcare Solutions · 20072cite it
  • K082023Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 20081cites it
  • K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions · 20081cites it
  • K070059Reprocessed TrocarsAscent Healthcare Solutions · 20071cites it
  • K081329Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 20081cites it
  • K100254Reprocessed CS BI-Diectional Diagnostic Electrophysiology CatheterAscent Healthcare Solutions · 20101cites it

What has FDA decided for it lately?

  • K111600Reprocessed Hand Activate Sealer/DividerAscent Healthcare Solutions · 2011
  • K110189Reprocessed Electrosurgical InstrumentAscent Healthcare Solutions · 2011
  • K100909Reprocessed Compression SleevesAscent Healthcare Solutions · 20101 recall
  • K100254Reprocessed CS BI-Diectional Diagnostic Electrophysiology CatheterAscent Healthcare Solutions · 201027 recalls
  • K100537Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9, Twblue, GablueAscent Healthcare Solutions · 2010
  • K100080Reprocessed Trocars, Model B5LT and CB5LTAscent Healthcare Solutions · 20101 recall
  • K093702Reprocessed Ultrasonic Coagulating ShearsAscent Healthcare Solutions · 2010
  • K092425Reprocessed 3D Diagnostic Ultrasound Catheters, Model SNDSTR10Ascent Healthcare Solutions · 2009

All 21 as Ascent Healthcare Solutions →

What has been recalled?

35 recalls linked to its devices; the latest:

  • K100254Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETERApr 10, 2026Class II
  • K100254Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETERApr 10, 2026Class II
  • K100254Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETERApr 10, 2026Class II
  • K100254Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETERApr 10, 2026Class II
  • K100254CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY…Apr 10, 2026Class II
  • K100254BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETERApr 10, 2026Class II

Other applicant names beginning “Ascent”

FDA records each applicant name separately; these may or may not be the same firm.

Ascent Medical, LLC 1Ascent Consumer Products, Inc. 1Ascent Heatlhcare Solutions 1