Company · US
Intersurgical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2023. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
14recalls (2 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | 11 |
| BZA | Connector, Airway (Extension) | 8 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 5 |
| CBP | Valve, Non-Rebreathing | 2 |
| BSF | Absorber, Carbon-Dioxide | 1 |
| BYG | Mask, Oxygen | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
| CCW | Laryngoscope, Rigid | 1 |
| OFP | Anesthesia Breathing Circuit Kit (Adult & Pediatric) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 2023 | K223258 | TNI Clear-Guard™ 3 angled breathing filter (1545020) Intersurgical , Ltd., GB | CAH |
| Feb 12, 2015 | K141087 | INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF Intersurgical Incorporated | CAH |
| Jun 4, 2014 | K132143 | EXHALATION VALVE Intersurgical Incorporated | CBP |
| Mar 14, 2013 | K121747 | FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS Intersurgical Incorporated | BZD |
| Jan 10, 2013 | K122077 | MANOMETER Intersurgical, Inc. | CAP |
| Dec 20, 2012 | K122075 | DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER Intersurgical, Inc. | CCK |
| Nov 2, 2012 | K121026 | FLO-GUARD BREATHING FILTER Intersurgical, Inc. | CAH |
| Oct 29, 2010 | K092451 | INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER Intersurgical, Inc. | CAH |
| May 18, 2010 | K092129 | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 Intersurgical, Inc. | BZE |
| Mar 10, 2010 | K092409 | HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER Intersurgical, Inc. | CAH |
| May 13, 2004 | K032322 | CLEAR-THERM MICRO HME, MODEL 1441 Intersurgical, Inc. | CAH |
| Jun 24, 2003 | K024270 | CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3 Intersurgical, Inc. | CAH |
| Jun 15, 1999 | K990949 | CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT Intersurgical, Inc. | CAH |
| Apr 30, 1999 | K983610 | CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18 Intersurgical, Inc. | CAH |
| Jan 29, 1999 | K984481 | EXHALATION VALVE Intersurgical, Inc. | CBP |
| May 21, 1993 | K925462 | BREATHING FILTERS 1942T/1941T/2014T Intersurgical, Inc. | CAH |
| Jun 17, 1992 | K921512 | ENTENDED LINE ACCESSORIES & CONNECTORS Intersurgical, Inc. | BZA |
| Jun 17, 1992 | K921511 | CATHETER MOUNTS -- MODIFICATION Intersurgical, Inc. | BZA |
| Oct 23, 1991 | K911422 | DRUG NEBULIZERS Intersurgical, Inc. | CAF |
| Aug 26, 1991 | K911427 | BREATHING FILTERS Intersurgical, Inc. | CAH |
| Jun 24, 1991 | K911425 | ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM Intersurgical, Inc. | BZA |
| Jun 24, 1991 | K911421 | CATHETER MOUNTS Intersurgical, Inc. | BZA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Intersurgical Inc One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device. Open, Classified |
CAE | None listed |
| Aug 14, 2026 | Intersurgical Inc One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device. Open, Classified |
CAE | None listed |
| Aug 6, 2025 | Intersurgical Inc One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. Open, Classified |
CAE | None listed |
| Aug 6, 2025 | Intersurgical Inc One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. Open, Classified |
CAE | None listed |
| Jul 11, 2025 | Intersurgical Inc i-view video laryngoscope. Model Number: 8008000.
The i-view video laryngoscope is indicated to facilitate laryngoscopy. Open, Classified |
CCW | None listed |
| Oct 17, 2022 | Intersurgical Inc Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg
Model Number: 8003000 Terminated |
CAE | None listed |
| Nov 11, 2020 | Intersurgical Inc Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical Terminated |
OFP | None listed |
| Aug 7, 2019 | Intersurgical Inc Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector. Terminated |
BZA | K911421 |
| Aug 7, 2019 | Intersurgical Inc Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector. Terminated |
BZA | K911421 |
| Aug 7, 2019 | Intersurgical Inc Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector. Terminated |
BZA | K911425 |
| Aug 7, 2019 | Intersurgical Inc Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector. Terminated |
BZA | K911425 |
| Apr 25, 2018 | Intersurgical Inc Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000 Terminated |
CAI | None listed |
| Apr 3, 2017 | Intersurgical Inc Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalo Terminated |
BYG | None listed |
| Jan 11, 2012 | Intersurgical Inc The IS Can Disposable CO2 absorber x 6 ---
Carbon Dioxide absorbent for use on GE rebreathing systems ---
Manufactured in the United Kingdom for: Intersurgical Incorporated ---
417 Electronics Park Terminated |
BSF | None listed |