# K030580: Suretemp Plus

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: May 6, 2003 after 71 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
292 later devices descend from it; 2 cite it directly.
0 of 293 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K031740: VSM - Vital Signs Monitor, Model 53000 Series (2003), 290 descendants of its own
- K063725: MP5 Intellivue Patient Monitor (2007), 175 descendants of its own
- K071426: MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90  Intellivue Patient Monitors (2007), 151 descendants of its own
- K081793: Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry System Transceiver (2008), 143 descendants of its own
- K082633: Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 (2008), 127 descendants of its own

## Recalls of this device
- Sep 17, 2025 · Class II · Z-0233-2026: 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 d

## Indications for use
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.

Source page: https://510kreport.com/device/K030580
Methodology: https://510kreport.com/methodology