510(k) · Cleared

Cleared

Clinical Electronic Thermometer, Models TP11403 Through TP11413

K070342510(k) TraditionalCleared Mar 19, 200741-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

American I.V. Products, Inc. · FLL Continuous Measurement Thermometer

Cleared on Mar 19, 2007 as substantially equivalent to K992638 (Critikon Company, LLC, 2000) and 4 other predicates after a 41-day review. Its family tree reaches back 4 generations to 1989.

Decided: Mar 19, 2007
Review: 41 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 5

Its longest line of descent runs back 4 generations to K896030 (1989). 18 ancestors in all, the oldest K860436 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK896030 Hewlett-Packard Model M1016A CO2 & M1017A FI02Hewlett-Packard Co. · 1989
3 generations backK955113 Dinamap Select Multi-Parameter SystemJohnson & Johnson Medical, Inc. · 1996
2 generations backK971569 Dinamap MPS Portable MonitorJohnson & Johnson Medical, Inc. · 1997
1 generation backK992638 Dinamap Pro Series Monitor, Models 100, 200, 300, 400Critikon Company, LLC · 2000
This deviceK070342 Clinical Electronic Thermometer, Models TP11403 Through TP11413American I.V. Products, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K896030	Hewlett-Packard Model M1016A CO2 & M1017A FI02	Hewlett-Packard Co.	1989	—
−3	K955113	Dinamap Select Multi-Parameter System	Johnson & Johnson Medical, Inc.	1996	—
−2	K971569	Dinamap MPS Portable Monitor	Johnson & Johnson Medical, Inc.	1997	—
−1	K992638	Dinamap Pro Series Monitor, Models 100, 200, 300, 400	Critikon Company, LLC	2000	—
0 (this device)	K070342	Clinical Electronic Thermometer, Models TP11403 Through TP11413	American I.V. Products, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1987	1	0
1990	1	0
1991	4	0
1992	1	0
1994	1	0
1995	2	0
1996	1	0
1997	1	0
2005	1	0

FIG. 1 — Lineage of K070342, 1989–2007Source: 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? (5)

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
*	K992638	Dinamap Pro Series Monitor, Models 100, 200, 300, 400 Summary page 1 …ary Name: Clinical Electronic Thermometer Predicate Device: These AIV devices are Substantially equivalent to the following legally marketed devices: Critikon Company: K992638, K874378 PIN - 8813 & 8814 Alaris Medical Systems: K050230, K955846, K860436 P/N -2885, 2886, 2887, 2888, 3880L, 3882L Descript…	Critikon Company, LLC	2000	—
*	K874378	Dinamap Vital Signs Monitor, Model 8100T Summary page 1 …Clinical Electronic Thermometer Predicate Device: These AIV devices are Substantially equivalent to the following legally marketed devices: Critikon Company: K992638, K874378 PIN - 8813 & 8814 Alaris Medical Systems: K050230, K955846, K860436 P/N -2885, 2886, 2887, 2888, 3880L, 3882L Description: AIV'…	Critikon Company, LLC	1987	—
*	K050230	Turbo Temp Trio Summary page 1 …e: These AIV devices are Substantially equivalent to the following legally marketed devices: Critikon Company: K992638, K874378 PIN - 8813 & 8814 Alaris Medical Systems: K050230, K955846, K860436 P/N -2885, 2886, 2887, 2888, 3880L, 3882L Description: AIV's Clinical Electronic Thermometers (also referred…	Cardinal Health, Alaris Products	2005	—
*	K955846	Model 2082 Temp Plus Iii Thermometer/Model 2087 Temp Plus Iii Wall Mount Thermometer Summary page 1 …AIV devices are Substantially equivalent to the following legally marketed devices: Critikon Company: K992638, K874378 PIN - 8813 & 8814 Alaris Medical Systems: K050230, K955846, K860436 P/N -2885, 2886, 2887, 2888, 3880L, 3882L Description: AIV's Clinical Electronic Thermometers (also referred to as Tem…	Y	1996	—
*	K860436	Ivac Model 2080 Electronic Thermometer Summary page 1 …es are Substantially equivalent to the following legally marketed devices: Critikon Company: K992638, K874378 PIN - 8813 & 8814 Alaris Medical Systems: K050230, K955846, K860436 P/N -2885, 2886, 2887, 2888, 3880L, 3882L Description: AIV's Clinical Electronic Thermometers (also referred to as Temperature…	Y	1986	—

Also cleared against K992638: 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)

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 18 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
1 of the 18 ancestors has a recall of any class.
3 other devices also cite its predicate K992638.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

The devices are intended to be used in a clinical setting, physicians' offices or other alternate care settings. The devices are reusable and are intended for the quantitative detection of body temperature, which can be obtained orally, under the arm (axially) or rectally by trained medical personnel.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070342 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070342: Clinical Electronic Thermometer, Models TP11403 Through TP11413.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070342

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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