# K993938: The Hommed Sentry, Model 1 Sentry

- Pathway: 510(k) (Traditional)
- Applicant: Hommed, LLC
- Decided: Mar 15, 2000 after 117 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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 K983796 (1999). 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)
- K983796: 6004 Nibp Monitor with Temperature, Bci Intl., Inc. (1999) Summary page 1.
- (no number) Welch Allyn 678 SureTemp Thermometer: named in the summary without a submission number

## Indications for use
The HomMed Model Sentry patient monitor system is for spot checking of adult or pediatric patient’s systolic, diastolic and mean arterial (MAP) blood pressures, pulse rate, SpO, oximetry and oral temperature. The device will provide fast, reliable NIBP measurements on patients when using the appropriate blood pressure cuff. The oximetry function operates with all OEM (BCI) oximetry sensors, providing SpO; and pulse rate on all patients from pediatric to adult patients. The electronic thermometry is intended for oral temperature measurements and is only compatible with the Welch Allyn thermometry probes and probe covers. The device is intended for use in clinical environments by health care providers and for home use by patients with retrospective review by health care providers. Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K993938
Methodology: https://510kreport.com/methodology