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

FLK — Predicate Candidate Screening

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

72 daysmedian FDA review time

152 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days
K960185	AMSINO CLINICAL THERMOMETER	Amsia Intl., Inc.	1996-03-28	72
K960224	GERATHERM MERCUIRY FREE CLINICAL THERMOMETER	Rg Ent., Inc.	1996-03-25	68
K953465	KENTEMP	Kentron Health Care, Inc.	1995-12-15	144
K942483	CLINICAL GLASS THERMOMETER	Makol Medical Instruments Corp.	1995-03-28	307
K941673	MEDIAID UNIVERSAL THERMOMETER	Polymedica Industries, Inc.	1994-08-25	142
K940380	AMG MED BRAND CLINICAL GLASS THERMOMETER	Amg Medical, Inc.	1994-05-04	98
K940394	AMG MED BRAND CLINICAL GLASS THERMOMETER	Technolab Industries (Canada) , Ltd.	1994-05-04	98
K932991	GUARDIAN AND ANDINO MODELS	Coltemp, Inc.	1994-01-28	224
K923225	LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME	Lorrex Health Products	1993-06-08	342
K913793	SIMPEX INC. ORAL AND RECTAL THERMOMETERS	Simpex, Inc.	1991-12-30	129
K911269	MERCURY AND GLASS FEVER THERMOMETER	Steridyne Corp.	1991-05-15	54
K902625	CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT	Liaoning-Usa Corp.	1990-10-26	134
K903500	MASCOT THERMOTER	Mascot, Inc.	1990-10-09	67
K901790	THERMOMETER, MERCURY/CLINICAL	Perlink USA, Inc.	1990-07-11	83
K900646	MERCURY THERMOMETERS (ORAL AND RECTAL)	Abel Industries, Inc.	1990-07-11	152
K897054	CLINICAL MERCURY THERMOMETER	Cypress Medical Products, Ltd.	1990-03-22	94
K893602	GLASS MERCURY FILLED THERMOMETERS	Smith & Nephew United, Inc.	1989-08-08	85
K883573	THERMOMETER, MERCURY/CLINICAL	Umax Corp.	1988-11-07	77
K870285	THERMOMETER SHEATHES, STERILE (GLASS)	The Medical Group, Inc.	1987-02-12	16
K852301	INOX THERMOMETER JAR	Broadwest Corp.	1985-07-01	33
K822502	DISPOSABLE THERMOMETERS	Hudson Oxygen Therapy Sales Co.	1982-09-24	32
K813423	THERMOMETER SHEATHS	Abco Dealers, Inc.	1981-12-18	11
K813424	THERMOMETERS	Abco Dealers, Inc.	1981-12-18	11
K811631	THERMOMETER (MADE IN CHINA)	Robert I. Chien & Assoc., Inc.	1981-07-20	41
K801791	FERTILITY AWARENESS METHOD KIT	Telesis Corp.	1980-10-31	94
K792426	DISPOSABLE TEMPERATURE PROBE	Hospitak, Inc.	1980-01-16	49
K790891	TEMPO2-II DISPOSABLE THERMOMETERS	Airlife, Inc.	1979-06-27	51
K781817	OVU-GUIDE	Reproduction Research Laboratories	1978-12-04	35
K781106	THERMOMETER, EXACTA TEMP	S.M.B. Celsius Co., Inc.	1978-08-10	38
K780591	THERMOMETER KIT	Abco Dealers, Inc.	1978-04-19	9
K772365	THERMOMETER SHEATHS	Medline Industries, Inc.	1978-01-26	30
K770125	DISPOS-A-CARE THERMOMETER SHEATH	Chesebrough-Pond'S U.S.A. Co.	1977-03-14	52
K760552	THERMOMETER STAND AND DUST COVER	Landmark Plastics	1976-11-12	74

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