510(k) · Cleared

Cleared

Digital Clinical Thermometer, Models Act 2030, 2038

K021612510(k) SpecialCleared May 30, 200214-day reviewClass II21 CFR 880.2910

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

Actherm, Inc. · FLL Continuous Measurement Thermometer

Cleared on May 30, 2002 as substantially equivalent to K010238 (Actherm, Inc., 2001) after a 14-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: May 30, 2002
Review: 14 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010238 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK010238 Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010…Actherm, Inc. · 2001
This deviceK021612 Digital Clinical Thermometer, Models Act 2030, 2038Actherm, Inc. · 2002
Descendant · cites it directly · 0 of its ownK070028 Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal…Actherm, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all

K070028Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal, Lightweight-Probe…Actherm, Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010238	Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+…	Actherm, Inc.	2001	—
0 (this device)	K021612	Digital Clinical Thermometer, Models Act 2030, 2038	Actherm, Inc.	2002	—
+1	K070028	Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal…	Actherm, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K021612, 2001–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

Get a 510(k) Report

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
*	K010238	Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+, ACT2010+… Summary page 3 …n be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE…	Actherm, Inc.	2001	—

Also cleared against K010238: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K070028	Classic/Hypothermia, Flexible, 10-Second, Left-Right Handed, Basal, Lightweight-Probe…	Actherm, Inc.	2007	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K070028 (Actherm, Inc., 2007) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K010238.

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 Clinical thermometers, Models ACT 2030 and ACT 2038’s intended use are medical devices, supplied by internal power and intended to precisely measure human body temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K021612 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021612: Digital Clinical Thermometer, Models Act 2030, 2038.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021612

Report an extraction error

Are you the manufacturer?

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