510(k) · Cleared

Cleared

Unimed Temperature Probe

K121427510(k) TraditionalCleared May 29, 201215-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

Unimed Medical Supplies, Inc. · FLL Continuous Measurement Thermometer

Cleared on May 29, 2012 as substantially equivalent to K962070 (Yellow Springs Instrument Co., Inc., 1996) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1996. 8 later devices descend from it.

Decided: May 29, 2012
Review: 15 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K962070 (1996). 8 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 2 generations backK962070 Ysi 400 Series Atuoclavable Reusable Temperature ProbeYellow Springs Instrument Co., Inc. · 1996 · Recalled
1 generation backK050837 Reusable Temperature Probes (M1024254 Skin Temperature Probe…GE Healthcare · 2005
This deviceK121427 Unimed Temperature ProbeUnimed Medical Supplies, Inc. · 2012
Descendant · cites it directly · 1 of its ownK193338 Med-link Reusable Temperature Probes, Med-link Disposable…Shenzhen Med-Link Electronics Tech Co., Ltd. · 2020
Descendant · cites it directly · 0 of its ownK253162 Temperature probes (T2252-PG); Temperature probes (TCMA-AG)…Unimed Medical Supplies, Inc. · 2026
Descendant · cites it directly · 0 of its ownK243000 Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable…Shenzhen Medke Technology Co., Ltd. · 2025
Descendant · 2 generations on · 0 of its ownK223807 Reusable Temperature Probe, Disposable Temperature ProbeShenzhen Sino-K Medical Technology Co.,Ltd · 2023
Descendant · cites it directly · 0 of its ownK203636 PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS…Jkh USA, LLC · 2021

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2018high 2 (2019) · low 0 (2022)2026

Most influential descendants

Showing 5 of 8 · See all

K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature ProbesShenzhen Med-Link Electronics Tech Co., Ltd. · 2020 · cites it directly1descendant
K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes…Unimed Medical Supplies, Inc. · 2026 · cites it directly0descendants
K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe…Shenzhen Medke Technology Co., Ltd. · 2025 · cites it directly0descendants
K223807Reusable Temperature Probe, Disposable Temperature ProbeShenzhen Sino-K Medical Technology Co.,Ltd · 2023 · 2 generations on0descendants
K203636PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS…Jkh USA, LLC · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K962070	Ysi 400 Series Atuoclavable Reusable Temperature Probe	Yellow Springs Instrument Co., Inc.	1996	2
−1	K050837	Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable…	GE Healthcare	2005	—
0 (this device)	K121427	Unimed Temperature Probe	Unimed Medical Supplies, Inc.	2012	—
+1	K193338	Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes	Shenzhen Med-Link Electronics Tech Co., Ltd.	2020	—
+1	K253162	Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature…	Unimed Medical Supplies, Inc.	2026	—
+1	K243000	Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable…	Shenzhen Medke Technology Co., Ltd.	2025	—
+2	K223807	Reusable Temperature Probe, Disposable Temperature Probe	Shenzhen Sino-K Medical Technology Co.,Ltd	2023	—
+1	K203636	PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS…	Jkh USA, LLC	2021	—

Descendants by year cleared

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

FIG. 1 — Lineage of K121427, 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? (2)

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 …General Purpose Temperature Probe TMR-AG Unined General Purpose Temperature Probe Predicate Device: YSI 400 Series Autoclavable Temperature Probe (K962070) GE Reusable Temperature Probes (K050837) Indications for use Unined Temperature Probes are intended to be used for monitoring t…	Yellow Springs Instrument Co., Inc.	1996	2
*	K050837	Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable; M1024247, GP… Summary page 2 …MR-AG Unined General Purpose Temperature Probe Predicate Device: YSI 400 Series Autoclavable Temperature Probe (K962070) GE Reusable Temperature Probes (K050837) Indications for use Unined Temperature Probes are intended to be used for monitoring temperature. The temperature probes are re…	GE Healthcare	2005	—

Also cleared against K962070: 1 other device →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K193338	Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes	Shenzhen Med-Link Electronics Tech Co., Ltd.	2020	1
K253162	Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes…	Unimed Medical Supplies, Inc.	2026	0
K243000	Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe…	Shenzhen Medke Technology Co., Ltd.	2025	0
K203636	PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS…	Jkh USA, LLC	2021	0
K182751	Reusable Temperature Probe	Shenzhen Caremed Medical Technology Co., Ltd.	2019	0
K182667	Med-link Temperature Probes	Shenzhen Med-Link Electronics Tech Co., Ltd.	2019	0
K173194	Temperature Probe	Orantech, Inc.	2018	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?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
1 of the 2 ancestors has a recall of any class.
Of its descendants, K193338 (Shenzhen Med-Link Electronics Tech Co., Ltd., 2020) has gone furthest, with 1 descendant 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. 2012, this device’s year, is highlighted.

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?

Unimed Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes.

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121427 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121427: Unimed Temperature Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121427

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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