510(k) Report

510(k) · Cleared

Cleared

Temp Teller-Infrared Tympanic Thermometer, Models TT-200, TT-201

K984497510(k) TraditionalCleared May 26, 1999160-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

Oriental System Technology, Inc. · FLL Continuous Measurement Thermometer

Cleared on May 26, 1999 as substantially equivalent to K902912 (Thermoscan, Inc., 1990) and 4 other predicates after a 160-day review. Its family tree reaches back 1 generation to 1990.

Decided
May 26, 1999
Review
160 days
Class
Class II
Product code
FLL
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K902912 (1990). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestorK902912 · Thermoscan-Instant Thermometer Model IR-4000 · Thermoscan, Inc. · 1990199019921994199619982000
Other ancestors, by generation 1 generation back: 4 other ancestors K902912 · Thermoscan-Instant Thermometer Model IR-4000 · Thermoscan, Inc. · 19900
  1. Root · 1 generation backK902912 Thermoscan-Instant Thermometer Model IR-4000Thermoscan, Inc. · 1990
  2. This deviceK984497 Temp Teller-Infrared Tympanic Thermometer, Models TT-200, TT-201Oriental System Technology, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K902912Thermoscan-Instant Thermometer Model IR-4000Thermoscan, Inc.1990—
0 (this device)K984497Temp Teller-Infrared Tympanic Thermometer, Models TT-200, TT-201Oriental System Technology, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
199610
199710
FIG. 1 — Lineage of K984497, 1990–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K902912Thermoscan-Instant Thermometer Model IR-4000
Summary page 1
…ber 1998 2. Name of the Device: Temp Teller-Infrared Tympanic Thermometer, Models TT-200 and TT-201 3. Predicate Device Information: ThermoScan Instant Thermometer, K# 902912, K# 930680, K# 954523 and K# 964605, ThermoScan Inc. Omron Gentle Temp MC 505, K# 922344, Omron Health Care. 4. Device Descript…
Thermoscan, Inc.1990—
*K930680Thermoscan Instant Thermometer IR-5000
Summary page 1
…Name of the Device: Temp Teller-Infrared Tympanic Thermometer, Models TT-200 and TT-201 3. Predicate Device Information: ThermoScan Instant Thermometer, K# 902912, K# 930680, K# 954523 and K# 964605, ThermoScan Inc. Omron Gentle Temp MC 505, K# 922344, Omron Health Care. 4. Device Description: The O…
Thermoscan, Inc.1994—
*K954523Thermoscan Instant Thermometer Model IR-6000
Summary page 1
…e Device: Temp Teller-Infrared Tympanic Thermometer, Models TT-200 and TT-201 3. Predicate Device Information: ThermoScan Instant Thermometer, K# 902912, K# 930680, K# 954523 and K# 964605, ThermoScan Inc. Omron Gentle Temp MC 505, K# 922344, Omron Health Care. 4. Device Description: The OSTI Temp —…
Thermoscan, Inc.1996—
*K964605Braun Thermoscan Pro-2000 Instant Thermometer (Pro-2000)
Summary page 1
…Teller-Infrared Tympanic Thermometer, Models TT-200 and TT-201 3. Predicate Device Information: ThermoScan Instant Thermometer, K# 902912, K# 930680, K# 954523 and K# 964605, ThermoScan Inc. Omron Gentle Temp MC 505, K# 922344, Omron Health Care. 4. Device Description: The OSTI Temp — Teller Infrare…
Thermoscan, Inc.1997—
*K922344Omron Tympanic Thermometer MC-500
Summary page 1
…nd TT-201 3. Predicate Device Information: ThermoScan Instant Thermometer, K# 902912, K# 930680, K# 954523 and K# 964605, ThermoScan Inc. Omron Gentle Temp MC 505, K# 922344, Omron Health Care. 4. Device Description: The OSTI Temp — Teller Infrared Tympanic Thermometer, Models TT-200, TT-201, is an e…
Omron Healthcare, Inc.1993—

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?

  • None of the 5 ancestors has a recall.

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—

What is it indicated for?

The device is an electronic clinical thermometer using an infrared sensor to

detect body temperature from the auditory canal in the neonatal, pediatric and

adult population used in the home setting.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Oriental System Technology, Inc.

6 FDA decisions under this applicant name. See the company

  • K042202Tempteller - High Speed Digital Thermometers, Models DT-302, DT-312, DT-412, DT-502Oriental System Technology, Inc. · 2004
  • K030299Tempteller Infared Ear Thermometers, Model CT-31/31DX/32/32DXOriental System Technology, Inc. · 2003
  • K010235Tempteller Infrared Ear Thermometer, Model CT-30/ CT-30DXOriental System Technology, Inc. · 2001
  • K001008Tempteller Infrared Ear Thermometer, Models TT-901, TT-911 and TT-921Oriental System Technology, Inc. · 2000
  • K992601Temp Teller - Digital Thermometer, Models DT-101, DT-102, DT-103, DT-201, DT-202, DT-203Oriental System Technology, Inc. · 1999

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/K984497 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984497: Temp Teller-Infrared Tympanic Thermometer, Models TT-200, TT-201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984497

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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