510(k) · Cleared

Cleared

Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable; M1024247, GP Temperature Probe, Adult, Resuable

K050837510(k) TraditionalCleared Apr 27, 200526-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

GE Healthcare · FLL Continuous Measurement Thermometer

Cleared on Apr 27, 2005 as substantially equivalent to K962070 (Yellow Springs Instrument Co., Inc., 1996) after a 26-day review. Its family tree reaches back 1 generation to 1996. 14 later devices descend from it.

Decided: Apr 27, 2005
Review: 26 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962070 (1996). 14 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK962070 Ysi 400 Series Atuoclavable Reusable Temperature ProbeYellow Springs Instrument Co., Inc. · 1996 · Recalled
This deviceK050837 Reusable Temperature Probes (M1024254 Skin Temperature Probe…GE Healthcare · 2005
Descendant · cites it directly · 8 of its ownK121427 Unimed Temperature ProbeUnimed Medical Supplies, Inc. · 2012
Descendant · cites it directly · 5 of its ownK121999 General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013
Descendant · 2 generations on · 2 of its ownK181967 Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 2018
Descendant · 2 generations on · 1 of its ownK193338 Med-link Reusable Temperature Probes, Med-link Disposable…Shenzhen Med-Link Electronics Tech Co., Ltd. · 2020
Descendant · 2 generations on · 1 of its ownK182755 Disposable Temperature ProbeShenzhen Caremed Medical Technology Co., Ltd. · 2018

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2012high 3 (2018) · low 0 (2014)2026

Most influential descendants

Showing 5 of 14 · See all

K121427Unimed Temperature ProbeUnimed Medical Supplies, Inc. · 2012 · cites it directly8descendants
K121999General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013 · cites it directly5descendants
K181967Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 2018 · 2 generations on2descendants
K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature ProbesShenzhen Med-Link Electronics Tech Co., Ltd. · 2020 · 2 generations on1descendant
K182755Disposable Temperature ProbeShenzhen Caremed Medical Technology Co., Ltd. · 2018 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962070	Ysi 400 Series Atuoclavable Reusable Temperature Probe	Yellow Springs Instrument Co., Inc.	1996	2
0 (this device)	K050837	Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable…	GE Healthcare	2005	—
+1	K121427	Unimed Temperature Probe	Unimed Medical Supplies, Inc.	2012	—
+1	K121999	General Purpose Temperature Probe, Skin Temperature Probe	Draeger Medical GmbH	2013	—
+2	K181967	Disposable Temperature Probe	Shenzhen Launch Electrical Co., Ltd.	2018	—
+2	K193338	Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes	Shenzhen Med-Link Electronics Tech Co., Ltd.	2020	—
+2	K182755	Disposable Temperature Probe	Shenzhen Caremed Medical Technology Co., Ltd.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2018	3	0
2019	2	0
2020	2	0
2021	2	0
2023	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K050837, 1996–2026Source: 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

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
*	K962070	Ysi 400 Series Atuoclavable Reusable Temperature Probe Summary page 2 …ble; Ml 024251 GP Temperature Probe, Pediatric, reusable) are substantially equivalent in safety and effectiveness to the predicate YSI temperature probes (K962070). DEVICE DESCRIPTION as required by 807.92(a)(4) Reusable temperature probes (M1024254 Skin Temperature probe, reusable…	Yellow Springs Instrument Co., Inc.	1996	2

Also cleared against K962070: 1 other device →

What descends from it? (14)

See all 14

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K121427	Unimed Temperature Probe	Unimed Medical Supplies, Inc.	2012	8
K121999	General Purpose Temperature Probe, Skin Temperature Probe	Draeger Medical GmbH	2013	5
K203643	Sensatronic Reusable Temperature Probes	Sensatronic GmbH	2021	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 a recall.
Of its descendants, K121427 (Unimed Medical Supplies, Inc., 2012) has gone furthest, with 8 descendants of its own.
1 other device also cites its predicate K962070.

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 reusable temperature probes are intended to be used for monitoring temperature. The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes.

These devices are indicated for use by qualified medical personnel only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050837 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050837: Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable; M1024247, GP Temperature Probe, Adult, Resuable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050837

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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