510(k) · Cleared

Recalled · 2011

Digital Thermometer, Models MT-XX8 and MT-XX9

K041516510(k) TraditionalCleared Sep 8, 200496-day reviewClass II21 CFR 880.2910Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vega Technologies, Inc. · FLL Continuous Measurement Thermometer

Cleared on Sep 8, 2004 as substantially equivalent to K021048 (Z7 International, 2002) after a 96-day review. Its family tree reaches back 1 generation to 2002. It has been recalled once.

Decided: Sep 8, 2004
Review: 96 days
Class: Class II
Product code: FLL
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K021048 (2002). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK021048 Thermometer Models ST8631Z7 International · 2002
This deviceK041516 Digital Thermometer, Models MT-XX8 and MT-XX9Vega Technologies, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K021048	Thermometer Models ST8631	Z7 International	2002	—
0 (this device)	K041516	Digital Thermometer, Models MT-XX8 and MT-XX9	Vega Technologies, Inc.	2004	—

FIG. 1 — Lineage of K041516, 2002–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FLL device

#1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K021048	Thermometer Models ST8631 Summary page 1 …803 2. Name of the Device: VEGA Digital Thermometer, models MT-XXS and MT-XX9. 3. Information ofthe 510(k) Cl-eare-d Device (Prdiat Device) ST8631 (K021 048). 4.DeieDsrpin thermometers by The D…	Z7 International	2002	—

Also cleared against K021048: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 23, 2011	Not classified	Z-0506-2012	Labeling design	The thermometers have been reported to have inaccurate readings

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
3 other devices also cite its predicate K021048.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLL

6in 2025

2007high 43 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLL

131in 2025

2007high 295 (2023) · low 59 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FLL

1in 2025

2007high 5 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FLL

73in 2025

2007high 142 (2022) · low 4 (2007)2025

MAUDE reports naming product code FLL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	15	81	0	4
2008	14	59	0	13
2009	13	84	0	9
2010	24	88	0	9
2011	20	113	1	18
2012	17	126	0	26
2013	14	149	0	16
2014	7	199	0	54
2015	3	270	1	53
2016	22	157	0	58
2017	16	174	2	118
2018	35	209	1	51
2019	22	198	5	52
2020	21	194	0	53
2021	43	218	0	115
2022	24	218	0	142
2023	17	295	0	101
2024	13	223	0	118
2025	6	131	1	73
2026	2	—	1	—

What is it indicated for?

The Digital Thermometer, models MT-XX8 and MT-XX9 are the battery-operated electronic devices with intended use of measuring human body temperature precisely. It can be measurement of oral, axially and rectal temperature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041516 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041516: Digital Thermometer, Models MT-XX8 and MT-XX9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041516

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026