Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

KLK — Predicate Candidate Screening

47 FDA 510(k) clearances under this product code; the 50 most recent screened below.

60 daysmedian FDA review time

248 days90th percentile

47clearances measured

K-number	Device	Applicant	Decided	Review days
K003943	MICROGAS 7650 TRANSCUTANEOUS MONITOR	Linde Medical Sensors AG	2001-05-04	134
K991644	MICROGAS 7650 TRANSCUTANEOUS MONITOR	Linde Medical Sensors AG	1999-05-21	8
K980287	SIEMENS SC9000/SC9015 TCP02/C02 MODULE	Siemens Medical Solutions USA, Inc.	1998-08-12	198
K924709	SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE	Air-Shields, Inc.	1996-01-17	1216
K924679	OXYCARE(TM) OXYGEN CONTROLLER/MONITOR	Air-Shields Vickers, Inc.	1995-02-21	888
K925910	HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE	Hewlett-Packard Co.	1993-07-29	248
K893133	HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX	Mennen Medical, Inc.	1989-07-14	80
K870805	MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR	Novametrix Medical Systems, Inc.	1987-05-27	85
K861861	515A NEO-TRAK NEONATAL MONITOR	Ge Medical Systems Information Technologies	1986-07-10	57
K860124	HORIZON 2000 TRANSCUTANEOUS GAS MONITORING	Mennen Medical, Inc.	1986-05-09	115
K860951	KONTRON CUTANEOUS PO2 MONITOR 820	Kontron Instruments, Inc.	1986-04-09	28
K852959	PO-510 TCPO2 MONITOR	Sumitomo Electric Industries, Inc.	1985-11-29	140
K851451	STAT GAS MODULE	Vulcan Laboratories, Inc.	1985-08-02	113
K844253	NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2	Novametrix Medical Systems, Inc.	1985-01-10	69
K844079	NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN	Novametrix Medical Systems, Inc.	1984-11-30	42
K842497	SERVOMED OXYMONITO SMK 363	Litton Datamedix	1984-10-04	100
K842374	NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN	Novametrix Medical Systems, Inc.	1984-09-17	91
K840993	TRANSCUTANEOUS 800-OXYGEN MONITORS/801	Novametrix Medical Systems, Inc.	1984-04-24	47
K840918	MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT	Biochem International, Inc.	1984-04-17	47
K840919	DAYPAK SYS VII CATHETER CARE KIT	Creative Care Systems, Inc.	1984-04-17	47
K831319	PATIENT MONITOR #404	Analogic Corp.	1984-03-22	335
K834057	IL 301 PORTABLE TRANSCUT. OXYGEN MONI	Instrumentation Laboratory CO	1984-02-04	73
K832652	OXY MONITOR 5-RANGE DUAL-THERMISTOR	Litton Medical Electronics	1983-12-22	136
K830197	TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS	Diamond Shamrock Corp.	1983-11-29	313
K831744	TRANSCUTANEOUS OXYGEN MONITOR OPTION	Ge Medical Systems Information Technologies	1983-07-19	49
K831460	AS 30/TCP MODULE	Narco Scientific	1983-07-12	67
K822328	IL 301 TRANSCUTANEOUS OXYGEN MONITOR	Instrumentation Laboratory CO	1982-09-07	35
K821936	CRITIKON OXYGEN MONITOR, MODEL 8030	Critikon Company, LLC	1982-08-16	48
K813350	NOVAMETRIX MODEL 807 TRANSCUT. MONITOR	Novametrix Medical Systems, Inc.	1982-02-12	77
K813347	CRITIKON TRANSCUTANEOUS GAS MONITORS	Critikon Company, LLC	1982-01-26	60
K813352	NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN	Novametrix Medical Systems, Inc.	1982-01-07	41
K813351	NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER	Novametrix Medical Systems, Inc.	1981-12-31	34
K812167	MODEL 78850 OXYGEN MONITOR	Hewlett-Packard Co.	1981-08-31	32
K811836	PO-200 BLOOD OXYGEN MONITOR	Sumitomo Electric Industries, Inc.	1981-07-27	27
K810999	CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS	Cordis Corp.	1981-06-24	72
K811470	LIFESPAN 100	Biochem International, Inc.	1981-06-12	17
K802978	TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300	Brattle Instrument Corp.	1981-02-02	73
K802846	TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.	The London Co.	1980-12-17	35
K800988	NOVAMETRIX TCOMETTE #809 TRANS. MONITOR	Novametrix Medical Systems, Inc.	1980-05-28	34
K800631	OXYMETER	Dragerwerk AG	1980-04-02	13
K791559	ROCHE SENSOR ADAPTOR	Roche Medical Electronics, Inc.	1979-11-21	96
K792011	TC02M PRECISION GAS CALIBRATOR	Novametrix Medical Systems, Inc.	1979-11-16	42
K792009	TC02 M OXYGEN ELECTRODE CONTACT	Novametrix Medical Systems, Inc.	1979-10-26	21
K792010	TC02M ELECTRODE ADHESIVE RINGS	Novametrix Medical Systems, Inc.	1979-10-26	21
K791152	TCO2M MODEL 818	Novametrix Medical Systems, Inc.	1979-08-03	45
K781910	MONITOR, SENSOMATIII OXYGEN	Biochem International, Inc.	1978-12-26	42
K780458	TRANSCUTANEOUS OXYGEN PERFUSION MONITOR	Narco Air-Shields	1978-10-10	201

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda