Mesa Laboratories Inc

Denver, CO, US

MESA LABORATORIES, INC. appears in FDA device records in Denver, CO. FDA records list 9 510(k) clearances between 2004-02-27 and 2020-09-02, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 7 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 9
PMA records: 0
Recall records: 7
Registered establishments: 2

FDA records under these names

3 names

FDA records resolved to Mesa Laboratories Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Mesa Laboratories Bozeman Manufacturing Facilityenforcement report, recall
Mesa Laboratories Bozeman Manufacturing Facility (Zoot)registration
Mesa Laboratories, Inc., Bozeman Manufacturing Facilityenforcement report, recall

510(k) clearance history

FDA records hold 9 510(k) clearances for Mesa Laboratories Inc between 2004 and 2020. The busiest year on record is 2013, with 2. The most recent is 2020, with 1.

Clearances by year, as a table

510(k) clearance decisions for Mesa Laboratories Inc, by decision year
Year	Clearances
2004	1
2005	1
2012	1
2013	2
2014	1
2015	1
2019	1
2020	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K201765	SmartHDM-510 System	FIZ	Substantially Equivalent	2020-09-02
K191496	TDS Standard Solution	FKH	Substantially Equivalent	2019-08-05
K150657	Phoenix XL Dialysate Meter	FIZ	Substantially Equivalent	2015-09-21
K140589	STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR	FRC	Substantially Equivalent	2014-12-03
K130100	COMINED STANDARD SOLUTION	FKH	Substantially Equivalent	2013-04-18
K122362	SMART-WELL INCUBATOR	FRC	Substantially Equivalent	2013-03-26
K112018	SMART READ EZTEST STEAM	FRC	Substantially Equivalent	2012-01-30
K050812	90XL INSTRUMENTATION SYSTEM	FIZ	Substantially Equivalent	2005-05-05
K033330	CONDUCTIVITY/TDS CALIBRATOR SOLUTION	FKH	Substantially Equivalent	2004-02-27

Registered establishments

FDA registered establishments for Mesa Laboratories Inc, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1720309	1720309	MESA LABORATORIES, INC.	12100 W 6th Ave, Denver, CO 80228 US	2026	BYX FIP FIZ FKH FRC JCC
3013667284	3013667284	Mesa Laboratories Bozeman Manufacturing Facility (Zoot)	625 Zoot Way, Bozeman, MT 59718 US	2026	FRC JOJ

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1274-2018	SporAmpule Biological Indicator Catalog Number SPS5-100	The concentration of bromocresol purple in the recalled lots does not conform to specification.	Class II	2018-02-12	Terminated
Z-1273-2018	ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471	The concentration of bromocresol purple in the recalled lots does not conform to specification.	Class II	2018-02-12	Terminated
Z-2159-2017	MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS measurement instruments. The conductivity/TDS cells and instruments may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and do not come into contact with the patient.	Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications.	Class II	2017-05-12	Terminated
Z-1104-2017	ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.	Product resistance has fallen outside of label claim within expiry.	Class II	2016-04-04	Terminated
Z-0175-2014	pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold individually or in cartons with 6 bottles per box (for quart bottles only). Used in the hemodialysis setting to calibrate pH meters.	Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth.	Class II	2013-09-13	Terminated
Z-1868-2013	Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.	Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.	Class II	2013-06-04	Terminated
Z-1867-2013	Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.	Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.	Class II	2013-06-04	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain