Who else makes this device?

Name: tc Sensor 84
Brand: tc Sensor 84

Tc Sensor 84 · Monitor, Carbon-Dioxide, Cutaneous → Anesthesiology

1manufacturer

1catalogue number

2510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LKD
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77

Record

Regulatory record for tc Sensor 84
Listed by	Radiometer Medical APS, Denmark
FDA product code	LKD
Device type	Monitor, Carbon-Dioxide, Cutaneous
Device class	Class 2
Regulation	21 CFR 868.2480
Establishment	Complaint-file establishment, Manufacturer
Record published	2016-09-01
Record revised	2026-05-29 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, serial number
Storage	Storage environment temperature -10 to 50 °C

Catalogue Numbers

Catalogue numbers for tc Sensor 84
Catalogue number	Size	Status
945-737		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
TCM4x Cable	Radiometer Medical APS	5
Sechrist Industries, Inc.	Sechrist Industries, Inc.	3
TC pO2/pCO2 Membraning kit For TC electrode	Radiometer Medical APS	2
TC electrode	Radiometer Medical APS	2
Fixation kit N20	Radiometer Medical APS	1
TC pO2/pCO2 electrode	Radiometer Medical APS	1
Calibration Gas	Radiometer Medical APS	1
TCM4XX ETX Serial adapter, cable for TCM4XX ETX	Radiometer Medical APS	1
TCM Tosca module	Radiometer Medical APS	1
Extension cable For TCM3 electrodes, 3m	Radiometer Medical APS	1
Philips IntelliVue TcG10	Philips Medizin Systeme Böblingen GmbH	1
TCM4 combi module, TCpO2/O2 combi module	Radiometer Medical APS	1

Showing 12 of 23. All products under Monitor, Carbon-Dioxide, Cutaneous

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K093154	2010-02-05
K043003	2005-03-01

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2020-02-20	Class II	Under Investigation by firm	Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potentially compromise the product performance	84 units	2022-06-24

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P840037	1986-11-19	MODEL 515 NEONATAL MONIOTR	GE Medical Systems Information Technologies, Inc.
P850087	1986-11-14	LITTON TRANSCUTANEOUS CO2 SYSTEM	Litton Datamedix
P820019	1986-03-03	LIFESPAN(TM) 100 TCPCO2 MONITOR	Biochem International, Inc.
P810022	1985-11-21	TCO2M MODEL 818 MONITOR	Novametrix Medical Systems, Inc.
P830008	1984-10-29	CUTANIOUS GAS MONITOR	Sensor Medics Corp.
P820025	1984-04-18	TCPCO2 MONITORING SYSTEM	Narco Scientific
P800043	1984-03-01	RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO	Radiometer America, Inc.
P810037	1982-12-22	KONTRON CUTANEOUS PCO2 MONITOR	Kontron Cardiovascular

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Tc Sensor 84