# K983355: Sabratek Apm-2000 Ambulatory Patient Montor, Transcutaneous Temperature Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Sabratek Corp.
- Decided: Mar 12, 1999 after 170 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
Longest line of descent: 1 generation back to K833568 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833568: Diatek 600 Thermometer System, Diatek, Inc. (1984) Summary page 1.
- (no number) Deep Body Thermometers Limited: named in the summary without a submission number

## Indications for use
Measures and displays patient temperature as calibrated to the equivalent oral temperature standard. The APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor is an element of the Sabratek Corporation APM-2000 System.

Source page: https://510kreport.com/device/K983355
Methodology: https://510kreport.com/methodology