510(k) · Cleared
ClearedMC-245, MC-246, MC-247, MC-341, MC-343, MC-344
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · FLL Continuous Measurement Thermometer
Cleared on Sep 1, 2009 as substantially equivalent to K881446 (Ormon Electronics, Inc., 1988) after an 84-day review. Its family tree reaches back 1 generation to 1988. 7 later devices descend from it.
- Decided
- Sep 1, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K881446 (1988). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK881446 Ormon Digital Fever Thermometer Model MC-3BOrmon Electronics, Inc. · 1988
- This deviceK091676 MC-245, MC-246, MC-247, MC-341, MC-343, MC-344Omron Healthcare, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK122520 Digital ThermomterTaidoc Technology Corporation · 2013
- Descendant · cites it directly · 1 of its ownK152680 TD-1035 ThermometerTaidoc Technology Corporation · 2016
- Descendant · 2 generations on · 1 of its ownK133111 Kingtech Digital ThermometerKingtech Enterprise, Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK101043 Ect Digital ThermometerChangshan Estar Electronics Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK172733 TD-1035 ThermometerTaidoc Technology Corporation · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K122520Digital ThermomterTaidoc Technology Corporation · 2013 · cites it directly2descendants
- K152680TD-1035 ThermometerTaidoc Technology Corporation · 2016 · cites it directly1descendant
- K133111Kingtech Digital ThermometerKingtech Enterprise, Ltd. · 2013 · 2 generations on1descendant
- K101043Ect Digital ThermometerChangshan Estar Electronics Co., Ltd. · 2010 · cites it directly1descendant
- K172733TD-1035 ThermometerTaidoc Technology Corporation · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881446 | Ormon Digital Fever Thermometer Model MC-3B | Ormon Electronics, Inc. | 1988 | — |
| 0 (this device) | K091676 | MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 | Omron Healthcare, Inc. | 2009 | — |
| +1 | K122520 | Digital Thermomter | Taidoc Technology Corporation | 2013 | — |
| +1 | K152680 | TD-1035 Thermometer | Taidoc Technology Corporation | 2016 | — |
| +2 | K133111 | Kingtech Digital Thermometer | Kingtech Enterprise, Ltd. | 2013 | — |
| +1 | K101043 | Ect Digital Thermometer | Changshan Estar Electronics Co., Ltd. | 2010 | — |
| +2 | K172733 | TD-1035 Thermometer | Taidoc Technology Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2013 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 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? (1)
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 |
|---|---|---|---|
| * | K881446 | Ormon Digital Fever Thermometer Model MC-3BSummary page 1…ice: Models - MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 Predicate Devices: Omron - MC-313 - K88 1446 Device Description: These are simple electronic thermometer which is a thermistor to measure temperature. *All the functio… | 1988 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K122520 (Taidoc Technology Corporation, 2013) has gone furthest, with 2 descendants 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. 2009, this device’s year, is highlighted.
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 Omron electronic thermometer Models MC-245, MC-246, MC-341, MC-343, and MC-344 are intended to measure the body temperature either oral, axillaries (under arm) and rectal and Model - MC-247 measure the body temperature oral (basal) and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091676: MC-245, MC-246, MC-247, MC-341, MC-343, MC-344.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091676
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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