510(k) · Cleared

Cleared

Sabratek Patient Home Management System

K980619510(k) TraditionalCleared Aug 20, 1998183-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sabratek Corp. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Aug 20, 1998 as substantially equivalent to K951246 (Protocol Systems, Inc., 1996) and 3 other predicates after a 183-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.

Decided: Aug 20, 1998
Review: 183 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K871720 (1987). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK871720 Modified Model UA-731 Digital SphygmomanometerA&D Engineering, Inc. · 1987
This deviceK980619 Sabratek Patient Home Management SystemSabratek Corp. · 1998
Descendant · cites it directly · 0 of its ownK993643 Nexsystem Ambulatory Patient Monitor Model Nex 100Nexan Telemed, Ltd. · 1999

Most influential descendants

Showing 1 of 1 · See all

K993643Nexsystem Ambulatory Patient Monitor Model Nex 100Nexan Telemed, Ltd. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871720	Modified Model UA-731 Digital Sphygmomanometer	A&D Engineering, Inc.	1987	—
0 (this device)	K980619	Sabratek Patient Home Management System	Sabratek Corp.	1998	—
+1	K993643	Nexsystem Ambulatory Patient Monitor Model Nex 100	Nexan Telemed, Ltd.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1996	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K980619, 1987–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MHX? 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 MHX device

#1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (7)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K951246	Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography Options Summary page 4 …connected to the VHRC. COMPARISON BETWEEN SABRATEK PATIENT HOME MONITORING SYSTEM (PHMS) PREDICATF DEVICES Predicate Device Parameter Respiration \| Propag® Encore (K#951246) Measure respiration rate Yes Range 2-150 RPM Accuracy + 2 RPM or 2% Sensor Pro-Tech 1246 (K#960851) Electrocardiogram \| Propag®…	Protocol Systems, Inc.	1996	—
*	K960851	Thermistor Cannula Style,Single Element,Adam Shell Thermistor Airflow Sensor Summary page 4 …DEVICES Predicate Device Parameter Respiration \| Propag® Encore (K#951246) Measure respiration rate Yes Range 2-150 RPM Accuracy + 2 RPM or 2% Sensor Pro-Tech 1246 (K#960851) Electrocardiogram \| Propag® Encore (K#951246) Records and stores monitor Yes bandwidth electrocardiogram Single lead (2 active…	Pro-Tech Services, Inc.	1996	—
*	K911529	Bunny Electrode/Stealth Electrode Pre Wired Eeg Summary page 4 …QRS Tone \| Yes Detects an electrode lead off Yes condition Alarms on low/high rate Yes Wireless operation Optional ECG Electrodes { Lead-Lok, Inc LLE306BX, { P-6 (K#911529) Patient Weight Scale \| AND Medical UC-300 K# Class I Exempt device \| 880.2700 Thermometric MA-200 Exempt device Nonin OEM I…	Lead-Lok, Inc.	1992	—
*	K871720	Modified Model UA-731 Digital Sphygmomanometer Summary page 4 …LLE306BX, { P-6 (K#911529) Patient Weight Scale \| AND Medical UC-300 K# Class I Exempt device \| 880.2700 Thermometric MA-200 Exempt device Nonin OEM II AND Medical K871720 Temperature Probe K# Pulse Oximetry Non Invasive Blood Pressure Ki# Page 4 summar2.doc 510(k) Submission, Sa…	A&D Engineering, Inc.	1987	—
*	—	AND Medical UC-300 Named without a submission number			—
*	—	MA-200 Named without a submission number			—
*	—	Nonin OEM II Named without a submission number			—

Also cleared against K951246: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K993643	Nexsystem Ambulatory Patient Monitor Model Nex 100	Nexan Telemed, Ltd.	1999	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 4 ancestors has a recall.
Of its descendants, K993643 (Nexan Telemed, Ltd., 1999) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K951246.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHX

8in 2025

2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007high 248 (2014) · low 57 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MHX

21so far in 2026, the most since 2007

2007high 21 (2026) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MHX

3,761in 2025

2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, 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	96	3	131
2008	16	58	2	232
2009	13	57	7	382
2010	20	90	13	955
2011	12	81	16	949
2012	16	88	11	676
2013	21	120	14	1,997
2014	13	248	6	1,609
2015	14	203	5	1,284
2016	13	149	7	1,105
2017	14	134	6	1,115
2018	11	203	12	2,157
2019	7	243	6	1,462
2020	11	196	0	1,714
2021	5	195	0	2,423
2022	15	189	6	1,470
2023	8	229	3	2,254
2024	5	181	3	2,814
2025	8	192	15	3,761
2026	14	205	21	—

What is it indicated for?

The Patient Home Monitoring System (PHMS) is a physiological data monitoring and communications system intended for use predominately in alternate care settings. It consists of an ambulatory, patient-worn monitor (the APM-2000), a communications module located in the patient care setting (the Virtual Hospital Room Communicator), and personal-computer-based data display and storage software (Remote Device Access Software, RDAS) located at the healthcare provider facility. The APM-2000 is a patient-worn physiological data recorder which stores ECG waveform data, temperature, respiration rate, arterial blood oxygen saturation, and pulse from non-invasive sensors.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980619 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980619: Sabratek Patient Home Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980619

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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