510(k) Report

FDA applicant

Intersurgical, Inc.

Liverpool, NY22 decisions1991–20234 recalls

FDA records 22 decisions for Intersurgical, Inc. (Liverpool, NY) from 1991 to 2023: 22 510(k) clearances. Most are in product codes CAH (Filter, Bacterial, Breathing-Circuit) and BZA (Connector, Airway (Extension)). Its devices cite 7 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Intersurgical Incorporated”, “Intersurgical , Ltd.”.

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 Intersurgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2010: 32012: 22013: 22014: 12015: 12023: 1
2007high 3 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

4in 2019

2019: 4
2007high 4 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Intersurgical, Inc.’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?

  • CAHFilter, Bacterial, Breathing-Circuit11decisions
  • BZAConnector, Airway (Extension)4decisions
  • CBPValve, Non-Rebreathing2decisions
  • CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)1decision
  • BZDVentilator, Non-Continuous (Respirator)1decision
  • BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer1decision

Also: CCK (1), CAF (1).

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 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.

  • K092129Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model 2026,2026-CH, 2310, 2320, 2330Intersurgical, Inc. · 20102cite it
  • K990949Clear-Guard II, Clear-Therm Hmef, Clear-Therm Hmef W/ Flextube, Clear Guard 11 W/ Gas Monitoring PortIntersurgical, Inc. · 19992cite it
  • K122075Disposable Gas Sampling Line with and Without in-Line FilterIntersurgical, Inc. · 20122cite it
  • K132143Exhalation ValveIntersurgical Incorporated · 20141cites it
  • K122077ManometerIntersurgical, Inc. · 20131cites it
  • K092409Hydro-Guard Mini Breathing Filter and Heat and Moisture Exchanger and Air-Guard Clear Breathing FilterIntersurgical, Inc. · 20101cites it

What has FDA decided for it lately?

  • K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)Intersurgical, Ltd. · 2023
  • K141087Inter-Therm Pediatric Hmef, Intern-Therm Mini Pediatric Angled HmefIntersurgical Incorporated · 2015
  • K132143Exhalation ValveIntersurgical Incorporated · 2014
  • K121747Facefit and Facefit Ported Non-Invasive Ventilation MasksIntersurgical Incorporated · 2013
  • K122077ManometerIntersurgical, Inc. · 2013
  • K122075Disposable Gas Sampling Line with and Without in-Line FilterIntersurgical, Inc. · 2012
  • K121026Flo-Guard Breathing FilterIntersurgical, Inc. · 2012
  • K092451Intersurgical Inter-Therm Breathing Filter and Heat and Moisture Exchanger, Intersurgical Inter-Guard…Intersurgical, Inc. · 2010

All 18 as Intersurgical, Inc. →All 3 as Intersurgical Incorporated →The one decision as Intersurgical, Ltd. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K911425Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway…Aug 7, 2019Class II
  • K911425Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway…Aug 7, 2019Class II
  • K911421Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF…Aug 7, 2019Class II
  • K911421Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF…Aug 7, 2019Class II