510(k) Report

FDA applicant

Confluent Surgical,Inc

Waltham, MA6 decisions2004–20093 recalls

FDA records 6 decisions for Confluent Surgical,Inc (Waltham, MA) from 2004 to 2009: 6 510(k) clearances. All are in product code FMF (Syringe, Piston). Its devices cite 6 predicates, 4 of them its own earlier devices. 3 recalls are linked to its devices, 3 Class I.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Confluent Surgical,Inc’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12008: 12009: 1
2007high 1 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

3in 2025

2025: 3, 3 Class I
2007high 3 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Confluent Surgical,Inc 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?

  • FMFSyringe, Piston6decisions

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K072790Confluent Surgical Extended Tip Applicator, Model 70-2008-008Confluent Surgical,Inc · 20081cites it
  • K042588Confluent Surgical Dual Liquid Applicator, Model 70-2005093Confluent Surgical,Inc · 20041cites it
  • K050998Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, AP-a-6063Confluent Surgical,Inc · 20051cites it
  • K061183Confluent Surgical Dual Liquid Applicator, Model 70-2005-093Confluent Surgical,Inc · 20061cites it

What has FDA decided for it lately?

  • K091315Covidien Extended Tip ApplicatorConfluent Surgical,Inc · 20093 Class I recalls
  • K072790Confluent Surgical Extended Tip Applicator, Model 70-2008-008Confluent Surgical,Inc · 2008
  • K070814Modification to Confluent Surgical Micromyst Applicator and Air PumpConfluent Surgical,Inc · 2007
  • K061183Confluent Surgical Dual Liquid Applicator, Model 70-2005-093Confluent Surgical,Inc · 2006
  • K050998Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, AP-a-6063Confluent Surgical,Inc · 2005
  • K042588Confluent Surgical Dual Liquid Applicator, Model 70-2005093Confluent Surgical,Inc · 2004

All 6 as Confluent Surgical,Inc →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K091315Extended Tip Applicator, 8CM, Box of 5.May 22, 2025Class I
  • K091315Extended Tip Applicator, 15 CM, Box of 5.May 22, 2025Class I
  • K091315Extended Tip Applicator 8CM, Box of 1.May 22, 2025Class I