Data / Medical devices / Hong Kong / Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.: FDA-registered device maker in Tsimshatsui, Kowloon, Hong Kong, 47 510(k) clearances and 2 PMA approvals
Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. is registered with the FDA (registration 3013500228) in Tsimshatsui, Kowloon, Hong Kong. It lists 77 device types. The FDA files 47 510(k) clearances and 2 PMA approvals under its listings, the newest dated December 1, 2025. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013500228
- Address
- Unit A, 27/F Railway Plaza 39 Chatham Road South, Tsimshatsui, Kowloon, Hong Kong, 000000
- Owner or operator
- Amphenol Critical Medical Technologies, LLC (10053883)
- Roles
- Exporter to the US
- First device listed
- January 19, 2017
- Registered through
- 2026
- Brand names listed
- Bovie Cord:Reusable Bipolar Forceps Cord, CABLE ECG X2 3/5-LD PHILIPS AHA 20CM/9IN, CABLE,MULTI FUNCTION,DPLX SHLD,7.5FT, Cable, ECG lead, Multi and Monolead ECG lead, reusable, IBP cable, Kendall DL 12 Pin Adapter, None and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 1, 2025 | K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) | DSA | Substantially Equivalent | Drägerwerk AG & Co. KGaA | accessdata.fda.gov |
| December 17, 2024 | K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | DPS | Substantially Equivalent | Philips Medizin Systeme Böblingen GmbH | accessdata.fda.gov |
| December 9, 2024 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | DYG | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| March 20, 2024 | K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O | MWI | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| August 11, 2023 | K230626 | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait SpO2 Attachment Accessory Band (Portrait AAB01), Portrait | MWI | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| June 9, 2023 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor | DQK | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| December 2, 2022 | K221141 | PageWriter TC35 Cardiograph | DPS | Substantially Equivalent | Medizin Systeme Boblingen GmbH | accessdata.fda.gov |
| November 22, 2021 | K211651 | Eclipse PRO | MWJ | Substantially Equivalent | Spacelabs Healthcare, Ltd. | accessdata.fda.gov |
| October 9, 2020 | K200510 | Multi-LinkTM X2 ECG Adapter and Leadwires | DSA | Substantially Equivalent | Vyaire Medical, Inc. | accessdata.fda.gov |
| November 16, 2018 | K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure Cable | DQK | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 22, 2017 | K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | DSA | Substantially Equivalent | Carefusion 303, Inc. | accessdata.fda.gov |
| January 18, 2017 | K162432 | Multi-Link X2 ECG Cable and Lead Wire System | DSA | Substantially Equivalent | Carefusion 2200, Inc. | accessdata.fda.gov |
| December 23, 2015 | K152330 | Expression MR400 MRI Patient Monitoring System | MWI | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| May 13, 2015 | K150310 | IntelliVue Patient Monitor | DSI | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH | accessdata.fda.gov |
| April 30, 2014 | K133882 | CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) | DXJ | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| October 18, 2013 | K130684 | PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| August 28, 2013 | K131414 | CARESCAPE MONITOR B850 | MHX | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| July 15, 2013 | K131382 | EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL | MWI | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| February 28, 2013 | K121999 | GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE | FLL | Substantially Equivalent | Draeger Medical GmbH | accessdata.fda.gov |
| July 18, 2012 | K121638 | ST80I STRESS TEST SYSTEM | DQK | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| June 6, 2012 | K121480 | ARIATELE TELEMETRY TRANSMITTER (96281) | MHX | Substantially Equivalent | Spacelabs Healthcare | accessdata.fda.gov |
| April 3, 2012 | K113144 | PAGEWRITER TC 20, 30, 50, 70 | DPS | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| March 22, 2012 | K113657 | INTELLIVUE PATIENT MONITOR | MHX | Substantially Equivalent | Philips Medizin Systeme Boblingen GmbH | accessdata.fda.gov |
| March 3, 2011 | K103142 | SPACELABS MULTI-PARAMETER MODULE | DSI | Substantially Equivalent | Spacelabs Healthcare, Inc. | accessdata.fda.gov |
| February 15, 2011 | K110287 | PHILIPS ECG LEADWIRE SET | DSA | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| March 12, 2010 | K093881 | TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR | DQA | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| November 24, 2009 | K093501 | ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION | MHX | Substantially Equivalent | Spacelabs Medical, Inc. | accessdata.fda.gov |
| January 28, 2009 | K083528 | SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022 | GEI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 19, 2008 | K082851 | MULTLINK CABLE AND LEADWIRE SYSTEM | DSA | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
| May 9, 2008 | K080999 | PAGEWRITER CARDIOGRAPH | DPS | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| September 20, 2005 | K051873 | DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES | FLL | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 21, 2005 | K050583 | MODEL 250 SERIES MATERNAL/FETAL MONITOR | HGM | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
| June 20, 2005 | K051367 | PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000 | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
| February 22, 2005 | K043572 | COMPATIBILITY ECG TRUNK CABLES | DSA | Substantially Equivalent | Datex-Ohmeda | accessdata.fda.gov |
| December 9, 2004 | K043103 | VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 | DXG | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| February 20, 2004 | K032979 | PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T | DQA | Substantially Equivalent | Philips Medical Systems, Inc. | accessdata.fda.gov |
| August 28, 2002 | K020550 | PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX | DSI | Substantially Equivalent | Datascope Corp. | accessdata.fda.gov |
| July 13, 2001 | K011837 | LIFECARD CF 7 DAY | MWJ | Substantially Equivalent | Reynolds Medical , Ltd. | accessdata.fda.gov |
| June 29, 2001 | K011000 | TRAM 2001 MODULE | MHX | Substantially Equivalent | General Electric Medical Systems Information Techn | accessdata.fda.gov |
| December 22, 2000 | K001955 | AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 | GEI | Substantially Equivalent | Aaron Medical Industries | accessdata.fda.gov |
| September 8, 2000 | K001725 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A | MKJ | Substantially Equivalent | Agilent Technologies, Inc. | accessdata.fda.gov |
| April 19, 2000 | K000961 | AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE | GEI | Substantially Equivalent | Aaron Medical Industries | accessdata.fda.gov |
| June 3, 1999 | K983996 | SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM | MHX | Substantially Equivalent | Spacelabs Medical, Inc. | accessdata.fda.gov |
| March 16, 1998 | K980582 | MULTI-LINK CABLE AND LEAD WIRE SYSTEMS | DSA | Substantially Equivalent | Marquette Medical Systems, Inc. | accessdata.fda.gov |
| September 26, 1994 | K934580 | DANTEC 13R45 BAR ELECTRODE | GXY | Substantially Equivalent | Dantec Medical, Inc. | accessdata.fda.gov |
| August 1, 1994 | K935782 | DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES | DXN | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| March 2, 1994 | K932842 | SPACELABS MEDICAL MODEL 90481 EEG MODULE | GWQ | Substantially Equivalent | Spacelabs Medical, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 27, 2017 | P160022 | X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower | MKJ | 52 | October 16, 2026 | accessdata.fda.gov |
| June 30, 2004 | P030054 | ST JUDE MEDICAL EPIC HF SYSTEM | NIK | 427 | August 12, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Programmable
- All makers of Electrode, Cutaneous
- All makers of Catheter, Oximeter, Fiber-Optic
- All makers of Adjunctive Predictive Cardiovascular Indicator
- All makers of Electrocardiograph
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.