510(k) · Cleared

Recalled · Class II · 2022

Ysi 400 Series Atuoclavable Reusable Temperature Probe

K962070510(k) TraditionalCleared Jul 19, 199652-day reviewClass II21 CFR 880.2910Recalls 2

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

Yellow Springs Instrument Co., Inc. · FLL Continuous Measurement Thermometer

Cleared on Jul 19, 1996 after a 52-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it. It has been recalled 2 times.

Decided: Jul 19, 1996
Review: 52 days
Class: Class II
Product code: FLL
Recalls: 2
Predicates: 0

15 later devices descend from it, 2 citing it directly.

This deviceK962070 Ysi 400 Series Atuoclavable Reusable Temperature ProbeYellow Springs Instrument Co., Inc. · 1996
Descendant · cites it directly · 14 of its ownK050837 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 · 2 generations on · 5 of its ownK121999 General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013
Descendant · 3 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

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2005high 3 (2018) · low 0 (2006)2026

Most influential descendants

Showing 5 of 15 · See all

K050837Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable; M1024247, GP…GE Healthcare · 2005 · cites it directly14descendants
K121427Unimed Temperature ProbeUnimed Medical Supplies, Inc. · 2012 · cites it directly8descendants
K121999General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013 · 2 generations on5descendants
K181967Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 2018 · 3 generations on2descendants
K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature ProbesShenzhen Med-Link Electronics Tech Co., Ltd. · 2020 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K962070	Ysi 400 Series Atuoclavable Reusable Temperature Probe	Yellow Springs Instrument Co., Inc.	1996	—
+1	K050837	Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable…	GE Healthcare	2005	—
+1	K121427	Unimed Temperature Probe	Unimed Medical Supplies, Inc.	2012	—
+2	K121999	General Purpose Temperature Probe, Skin Temperature Probe	Draeger Medical GmbH	2013	—
+3	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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
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 K962070, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K050837	Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable; M1024247, GP…	GE Healthcare	2005	14
K121427	Unimed Temperature Probe	Unimed Medical Supplies, Inc.	2012	8

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 7, 2022	Class II	Z-0926-2022	Device Design	Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
Mar 13, 2017	Class II	Z-0395-2018	Other	The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K050837 (GE Healthcare, 2005) has gone furthest, with 14 descendants of its own.

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	—

https://510kreport.com/device/K962070 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962070: Ysi 400 Series Atuoclavable Reusable 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/K962070

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026