# K943695: Suretemp

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Bioresearch Assoc.
- Decided: Apr 21, 1995 after 266 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
440 later devices descend from it; 4 cite it directly.
1 of 441 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982776: 9303 Neonatal/Adult Vital Signs Monitor (1998), 425 descendants of its own
- K033048: Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS (2004), 272 descendants of its own
- K050844: 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL (2005), 264 descendants of its own
- K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor (2006), 250 descendants of its own
- K072295: Capnostream 20 with A2 Adaptive Averaging Software (2007), 197 descendants of its own

Source page: https://510kreport.com/device/K943695
Methodology: https://510kreport.com/methodology