510(k) · Cleared
ClearedTemp Teller - Digital Thermometer, Models DT-101, DT-102, DT-103, DT-201, DT-202, DT-203
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oriental System Technology, Inc. · FLL Continuous Measurement Thermometer
Cleared on Oct 27, 1999 as substantially equivalent to K962497 (Faichney Medical Co., 1996) after an 85-day review. Its family tree reaches back 2 generations to 1985. 2 later devices descend from it.
- Decided
- Oct 27, 1999
- Review
- 85 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K852954 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK852954 B-D Digital Fever ThermometerBd Becton Dickinson Vacutainer Systems Preanalytic · 1985
- 1 generation backK962497 Q-Tips, Faichney, Private LabelFaichney Medical Co. · 1996
- This deviceK992601 Temp Teller - Digital Thermometer, Models DT-101, DT-102, DT-103…Oriental System Technology, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK042202 Tempteller - High Speed Digital Thermometers, Models DT-302, DT-312…Oriental System Technology, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK101232 Joinsoon Electronics MFG CO. LTD High Speed Digital Thermometer…Joinsoon Electronics Mfg Co, Ltd. · 2010
Most influential descendants
Showing 2 of 2 · See all- K042202Tempteller - High Speed Digital Thermometers, Models DT-302, DT-312, DT-412, DT-502Oriental System Technology, Inc. · 2004 · cites it directly1descendant
- K101232Joinsoon Electronics MFG CO. LTD High Speed Digital Thermometer, Model TC-001Joinsoon Electronics Mfg Co, Ltd. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852954 | B-D Digital Fever Thermometer | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985 | — |
| −1 | K962497 | Q-Tips, Faichney, Private Label | Faichney Medical Co. | 1996 | — |
| 0 (this device) | K992601 | Temp Teller - Digital Thermometer, Models DT-101, DT-102, DT-103, DT-201… | Oriental System Technology, Inc. | 1999 | — |
| +1 | K042202 | Tempteller - High Speed Digital Thermometers, Models DT-302, DT-312, DT-412… | Oriental System Technology, Inc. | 2004 | — |
| +2 | K101232 | Joinsoon Electronics MFG CO. LTD High Speed Digital Thermometer, Model TC-001 | Joinsoon Electronics Mfg Co, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K962497 | Q-Tips, Faichney, Private LabelSummary page 1…meler, Models DT-101, DT-102, DT-103, DT-201, DT-202, and DT-203. Predicate Device Infarmation: 1. Q-Tips®, Faichney, Private Label Clinical Electronic Thermometers K# 962497 2. Wallgreens PAP-WD Device Description: The OGTI Temp — Teller Digilal Thetnumeler, (Mudels DT-101, DT-102, DT-103, DT-201, D… | 1996 |
| * | — | Wallgreens PAP-WD Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042202 | Tempteller - High Speed Digital Thermometers, Models DT-302, DT-312, DT-412, DT-502 | 2004 | 1 |
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 14 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K042202 (Oriental System Technology, Inc., 2004) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 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 device is an electronic clinical thermometer using a thermistor to detect body temperature from the wal, anpil, and reclal in the neonatal, pediatiic and adult population used in the clinical and home testing.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992601 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992601: Temp Teller - Digital Thermometer, Models DT-101, DT-102, DT-103, DT-201, DT-202, DT-203.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992601
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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