510(k) · Cleared
Recalled · Class II · 2025Suretemp Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · FLL Continuous Measurement Thermometer
Cleared on May 6, 2003 after a 71-day review. The FDA summary names no predicate by number. 292 later devices descend from it. It has been recalled once.
- Decided
- May 6, 2003
- Review
- 71 days
- Class
- Class II
- Product code
- FLL
- Recalls
- 1
- Predicates
- 0
292 later devices descend from it, 2 citing it directly.
- This deviceK030580 Suretemp PlusWelch Allyn, Inc. · 2003
- Descendant · cites it directly · 290 of its ownK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- Descendant · 2 generations on · 175 of its ownK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- Descendant · 3 generations on · 151 of its ownK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- Descendant · 3 generations on · 143 of its ownK081793 Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A…Philips Medizin Systeme Boeblingen GmbH · 2008
- Descendant · 3 generations on · 127 of its ownK082633 Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · Recalled
Showing 5 of 292 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 292 · See all- K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003 · cites it directly290descendants
- K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 2 generations on175descendants
- K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 3 generations on151descendants
- K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH · 2008 · 3 generations on143descendants
- K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · 3 generations on127descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030580 | Suretemp Plus | Welch Allyn, Inc. | 2003 | — |
| +1 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| +2 | K063725 | MP5 Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| +3 | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| +3 | K081793 | Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2008 | — |
| +3 | K082633 | Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2008 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 12 | 0 |
| 2012 | 12 | 0 |
| 2013 | 13 | 0 |
| 2014 | 13 | 0 |
| 2015 | 14 | 0 |
| 2016 | 16 | 0 |
| 2017 | 15 | 0 |
| 2018 | 20 | 0 |
| 2019 | 16 | 0 |
| 2020 | 14 | 0 |
| 2021 | 9 | 0 |
| 2022 | 24 | 0 |
| 2023 | 20 | 0 |
| 2024 | 22 | 0 |
| 2025 | 26 | 0 |
| 2026 | 17 | 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?
The FDA summary names no predicate by number.
What descends from it? (292)
See all 2922 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 17, 2025 | Class II | Z-0233-2026 | Process control | Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031740 (Welch Allyn Protocol, Inc., 2003) has gone furthest, with 290 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.
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 Welch Allyn SureTempB Plus thermometer enables the health care professional 'to make an accurate prediction of a febrile, afebrile or hypothermic patient's oral temperature in approximately 4-6 seconds (in Normal mode). Pediatric Axillary (age 17 and younger) temperatures can be obtained in approximately 10-13 seconds. Adult Axillary temperatures (in Normal mode) can be obtained in approximately 12-15 seconds. Rectal temperatures (in Normal mode) can…
Read the full statement (146 words)
The Welch Allyn SureTempB Plus thermometer enables the health care professional 'to make an accurate prediction of a febrile, afebrile or hypothermic patient's oral temperature in approximately 4-6 seconds (in Normal mode). Pediatric Axillary (age 17 and younger) temperatures can be obtained in approximately 10-13 seconds. Adult Axillary temperatures (in Normal mode) can be obtained in approximately 12-15 seconds. Rectal temperatures (in Normal mode) can be obtained in approximately 10-13 seconds. Normal (predictive) mode is available for oral, rectal, and axillary use.
In the Monitor mode, the instrument provides the capability of accurate, long-term monitoring of actual oral, rectal or axillary temperature, and of following the temperatuire whether constant, increasing, or decreasing.
The SureTemp is a clinical grade thermometer intended for use by healthcare practitioners only; typically in a hospital, clinic, long- term care, or mobile health care environment. It is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030580 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030580: Suretemp Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030580
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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