# Intersurgical, Inc.

- Location (FDA's records): Liverpool, NY
- FDA decisions: 22 (1991–2023): 22 510(k) clearances
- Names in FDA's records: Intersurgical, Inc. (18); Intersurgical Incorporated (3); Intersurgical , Ltd. (1)
- Product codes: CAH (11), BZA (4), CBP (2), CAP (1), BZD (1), BZE (1), CCK (1), CAF (1)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 10 (1 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fisher & Paykel Allied Products, Ltd.: 2 (https://510kreport.com/company/fisher-paykel-allied-products)
- Resmed, Ltd.: 1 (https://510kreport.com/company/resmed)
- King Systems Corp.: 1 (https://510kreport.com/company/king-systems)
- Mallinckrodt Medical: 1 (https://510kreport.com/company/mallinckrodt-medical)
- Catheter Research, Inc.: 1 (https://510kreport.com/company/catheter-research)

## Firms that cite its devices most
- Pall Corp.: 1 (https://510kreport.com/company/pall)
- Cardinal Health 207, Inc.: 1 (https://510kreport.com/company/cardinal-health-207)
- Besmed Health Business Corp: 1 (https://510kreport.com/company/besmed-health-business)
- Meditera Tibbi Malzeme San VE Tic AS: 1 (https://510kreport.com/company/meditera-tibbi-malzeme-san-ve-tic)
- Foremount Enterprise Co., Ltd.: 1 (https://510kreport.com/company/foremount-enterprise)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)
- Plastiflex Group NV: 1 (https://510kreport.com/company/plastiflex-group)
- Datex-Ohmeda, Inc.: 1 (https://510kreport.com/company/datex-ohmeda)

## Its most-cited devices
- K092129: Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model 2026,2026-CH, 2310, 2320, 2330 (2010), cited by 2
- K990949: Clear-Guard II, Clear-Therm Hmef, Clear-Therm Hmef W/ Flextube, Clear Guard 11 W/ Gas Monitoring Port (1999), cited by 2
- K122075: Disposable Gas Sampling Line with and Without in-Line Filter (2012), cited by 2
- K132143: Exhalation Valve (2014), cited by 1
- K122077: Manometer (2013), cited by 1
- K092409: Hydro-Guard Mini Breathing Filter and Heat and Moisture Exchanger and Air-Guard Clear Breathing Filter (2010), cited by 1

## Recent decisions
- K223258: TNI Clear-Guard™ 3 angled breathing filter (1545020) (Jun 15, 2023)
- K141087: Inter-Therm Pediatric Hmef, Intern-Therm Mini Pediatric Angled Hmef (Feb 12, 2015)
- K132143: Exhalation Valve (Jun 4, 2014)
- K121747: Facefit and Facefit Ported Non-Invasive Ventilation Masks (Mar 14, 2013)
- K122077: Manometer (Jan 10, 2013)
- K122075: Disposable Gas Sampling Line with and Without in-Line Filter (Dec 20, 2012)
- K121026: Flo-Guard Breathing Filter (Nov 2, 2012)
- K092451: Intersurgical Inter-Therm Breathing Filter and Heat and Moisture Exchanger, Intersurgical Inter-Guard Breathing Filter (Oct 29, 2010)

Source page: https://510kreport.com/company/intersurgical