510(k) Report

FDA applicant

Mercury Medical

Clearwater, FL16 decisions1994–20144 recalls

FDA records 16 decisions for Mercury Medical (Clearwater, FL) from 1994 to 2014: 16 510(k) clearances. Most are in product codes CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) and BTL (Ventilator, Emergency, Powered (Resuscitator)). Its devices cite 13 predicates, 3 of them its own earlier devices. 4 recalls are linked to its devices, 2 Class I.

FDA’s records also spell it “Mercury Medical, Inc.”.

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

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

How often FDA has decided Mercury Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2009: 22010: 12014: 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2024

2013: 12015: 12024: 2, 2 Class I
2007high 2 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Mercury Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase4decisions
  • BTLVentilator, Emergency, Powered (Resuscitator)2decisions
  • BTMVentilator, Emergency, Manual (Resuscitator)2decisions
  • BXRMeter, Airway Pressure (Inspiratory Force)1decision
  • BYEAttachment, Breathing, Positive End Expiratory Pressure1decision
  • CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)1decision

Also: CAH (1), CCW (1), NHK (1), GXI (1), BWF (1).

Whose devices does it build on?

Its devices cite 13 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 3 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.

  • K954486Mercury Airway Pressure ManometerMercury Medical · 19963cite it
  • K031411Mini STATCO2 CO2 Detector, Model 10-55371Mercury Medical · 20033cite it
  • K021576Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370Mercury Medical · 20023cite it
  • K000073Mercury Medical Disposable Radiofrequency CannulaMercury Medical · 20002cite it
  • K954492Mercury Medical Expiratory Resistance Exerciser, ResistexMercury Medical · 19962cite it
  • K093913Mercury Medical T-Piece ResuscitatorMercury Medical, Inc. · 20101cites it

What has FDA decided for it lately?

  • K142096T-Piece ResuscitatorMercury Medical · 2014
  • K093913Mercury Medical T-Piece ResuscitatorMercury Medical, Inc. · 20102 Class I recalls
  • K090710Mercury CpapMercury Medical · 2009
  • K083056Neo-Stat CO2 <KGMercury Medical · 2009
  • K032593Mercury Medical Negative Inspiratory Force (Nif) Disposable MonometerMercury Medical · 2004
  • K031814STATCO2METER, Model 10-55372Mercury Medical · 2003
  • K031411Mini STATCO2 CO2 Detector, Model 10-55371Mercury Medical · 2003
  • K021576Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370Mercury Medical · 2002

All 15 as Mercury Medical →The one decision as Mercury Medical, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K093913Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part…Dec 10, 2024Class I
  • K093913Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency…Aug 30, 2024Class I
  • K093913Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece…Oct 22, 2015Class II
  • K000073Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model…Feb 26, 2013Class II

Other applicant names beginning “Mercury”

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

Mercury Enterprises, Inc. 3Mercury Computer Systems, Inc. 2Mercury Ent., Inc. D/B/A Mercury Medical 1Mercury Enterprizes Dba Mercury Medical 1Mercury Electronics (Scot), Ltd. 1