510(k) Report

510(k) · Cleared

Cleared

Reusable & Disposable Temp. Probes

K813459510(k) TraditionalCleared Mar 26, 1982115-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

Electromedics, Inc. · FLL Continuous Measurement Thermometer

Cleared on Mar 26, 1982 after a 115-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 40 later devices descend from it.

Decided
Mar 26, 1982
Review
115 days
Class
Class II
Product code
FLL
Recalls
None
Predicates
0

40 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2008: 3 descendants cleared2003: 1 descendant cleared2012: 4 descendants cleared2010: 3 descendants cleared1999: 1 descendant cleared2001: 1 descendant cleared2016: 2 descendants cleared2009: 1 descendant cleared2017: 3 descendants cleared2025: 2 descendants cleared2013: 2 descendants cleared2014: 1 descendant cleared2002: 1 descendant cleared2005: 1 descendant cleared2006: 2 descendants cleared2026: 2 descendants cleared2011: 1 descendant cleared2020: 2 descendants cleared2019: 2 descendants cleared2018: 1 descendant cleared2022: 1 descendant cleared2015: 1 descendant cleared2024: 1 descendant cleared19801990200020102020
  1. This deviceK813459 Reusable & Disposable Temp. ProbesElectromedics, Inc. · 1982
  2. Descendant · cites it directly · 39 of its ownK962928 Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc. · 1996 · Recalled
  3. Descendant · 2 generations on · 27 of its ownK980380 Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend…Diametrics Medical, Ltd. · 1999
  4. Descendant · 3 generations on · 17 of its ownK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
  5. Descendant · 4 generations on · 15 of its ownK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
  6. Descendant · 5 generations on · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

1996: 11999: 12001: 12002: 12003: 12005: 12006: 22008: 32009: 12010: 32011: 12012: 42013: 22014: 12015: 12016: 22017: 32018: 12019: 22020: 22022: 12024: 12025: 22026: 2
1996high 4 (2012) · low 0 (1997)2026

Most influential descendants

Showing 5 of 40 · See all
  • K962928Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc. · 1996 · cites it directly39descendants
  • K980380Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter…Diametrics Medical, Ltd. · 1999 · 2 generations on27descendants
  • K050702Neurosystems 1TM MonitorNeurosystems, LLC · 2005 · 3 generations on17descendants
  • K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006 · 4 generations on15descendants
  • K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · 5 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K813459Reusable & Disposable Temp. ProbesElectromedics, Inc.1982—
+1K962928Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc.19962
+2K980380Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+…Diametrics Medical, Ltd.1999—
+3K050702Neurosystems 1TM MonitorNeurosystems, LLC2005—
+4K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation2006—
+5K080217Component Neuromonitoring SystemMoberg Research, Inc.20081

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200110
200210
200310
200510
200620
200830
200910
201030
201110
201240
201320
201410
201510
201620
201730
201810
201920
202020
202210
202410
202520
202620
FIG. 1 — Lineage of K813459, 1982–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (40)

See all 40

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

NumberDeviceApplicantDecidedDescendants
K962928Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc.199639

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?

  • Of its descendants, K962928 (Camino Neurocare, Inc., 1996) has gone furthest, with 39 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

2007: 152008: 142009: 132010: 242011: 202012: 172013: 142014: 72015: 32016: 222017: 162018: 352019: 222020: 212021: 432022: 242023: 172024: 132025: 62026 (partial year): 2
2007high 43 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLL

131in 2025

2007: 81 days median2008: 59 days median2009: 84 days median2010: 88 days median2011: 113 days median2012: 126 days median2013: 149 days median2014: 199 days median2015: 270 days median2016: 157 days median2017: 174 days median2018: 209 days median2019: 198 days median2020: 194 days median2021: 218 days median2022: 218 days median2023: 295 days median2024: 223 days median2025: 131 days median
2007high 295 (2023) · low 59 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FLL

1in 2025

2011: 12015: 12017: 22018: 12019: 52025: 12026 (partial year): 1
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

2007: 42008: 132009: 92010: 92011: 182012: 262013: 162014: 542015: 532016: 582017: 1182018: 512019: 522020: 532021: 1152022: 1422023: 1012024: 1182025: 73
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007158104
20081459013
2009138409
2010248809
201120113118
201217126026
201314149016
20147199054
20153270153
201622157058
2017161742118
201835209151
201922198552
202021194053
2021432180115
2022242180142
2023172950101
2024132230118
20256131173
20262—1—

More from Electromedics, Inc.

41 FDA decisions under this applicant name. See the company

  • K934964Electromedics Tympanic Temperature SensorElectromedics, Inc. · 1994
  • K933832Electromedics HG (Hydrogel) Series Skin Temperature SensorElectromedics, Inc. · 1994
  • K934355Electromedics Blood Heat ExchangerElectromedics, Inc. · 1993
  • K930154EL2-Series Blood Collection ReervoirElectromedics, Inc. · 19931 recall
  • K926250Electromedics EL-Series Cardiotomy ReservoirElectromedics, Inc. · 1993

Recent decisions in FLL

The FLL category page

  • K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature…Unimed Medical Supplies, Inc. · 2026
  • K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd. · 2026
  • K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd. · 2025
  • K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd. · 2025
  • K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2025

https://510kreport.com/device/K813459 · printed Nov 6, 2026

Cite this page

510(k) Report. “K813459: Reusable & Disposable Temp. Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K813459

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