510(k) · Cleared

Cleared

Rhythmscan Precision 6000

K914577510(k) TraditionalCleared May 8, 1992206-day reviewClass II21 CFR 870.1425

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

Precision Health Care Systems, Inc. · DQK Computer, Diagnostic, Programmable

Cleared on May 8, 1992 after a 206-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.

Decided: May 8, 1992
Review: 206 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 0

8 later devices descend from it, 2 citing it directly.

This deviceK914577 Rhythmscan Precision 6000Precision Health Care Systems, Inc. · 1992
Descendant · cites it directly · 6 of its ownK031466 Iqmark Digital HolterBrentwood Medical Technology Corp. · 2003
Descendant · 2 generations on · 3 of its ownK063035 Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc. · 2007
Descendant · 3 generations on · 2 of its ownK073147 Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08Transoma Medical · 2007
Descendant · 3 generations on · 1 of its ownK083828 Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM…Transoma · 2009
Descendant · 2 generations on · 0 of its ownK142693 ZywieAI Software LibraryZywie, Inc. · 2015

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1998high 2 (2007) · low 0 (1999)2026

Most influential descendants

Showing 5 of 8 · See all

K031466Iqmark Digital HolterBrentwood Medical Technology Corp. · 2003 · cites it directly6descendants
K063035Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc. · 2007 · 2 generations on3descendants
K073147Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08Transoma Medical · 2007 · 3 generations on2descendants
K083828Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna, Personal…Transoma · 2009 · 3 generations on1descendant
K142693ZywieAI Software LibraryZywie, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K914577	Rhythmscan Precision 6000	Precision Health Care Systems, Inc.	1992	—
+1	K031466	Iqmark Digital Holter	Brentwood Medical Technology Corp.	2003	—
+2	K063035	Sleuth Implantable Ecg Monitoring System	Transnoma Medical, Inc.	2007	—
+3	K073147	Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08	Transoma Medical	2007	—
+3	K083828	Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna…	Transoma	2009	—
+2	K142693	ZywieAI Software Library	Zywie, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2003	1	0
2006	1	0
2007	2	0
2009	2	0
2015	1	0

FIG. 1 — Lineage of K914577, 1992–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQK? 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 DQK device

#1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031466	Iqmark Digital Holter	Brentwood Medical Technology Corp.	2003	6
K973751	MT-200	Schiller America, Inc.	1998	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?

Of its descendants, K031466 (Brentwood Medical Technology Corp., 2003) has gone furthest, with 6 descendants of its own.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007high 190 (2016) · low 64 (2010)2026

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

Recalls per year · DQK

1in 2025

2007high 24 (2024) · low 0 (2016)2026

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

Adverse event reports per year · DQK

433in 2025

2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, 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	13	83	4	18
2008	4	70	1	34
2009	12	93	2	40
2010	9	64	3	49
2011	12	69	2	55
2012	7	74	3	129
2013	13	68	1	180
2014	9	90	4	115
2015	7	125	2	131
2016	15	190	0	340
2017	7	146	2	252
2018	14	150	6	261
2019	15	113	1	218
2020	16	123	1	215
2021	16	132	1	351
2022	19	136	2	319
2023	21	133	2	340
2024	13	100	24	557
2025	22	95	1	433
2026	23	151	2	—

https://510kreport.com/device/K914577 · printed Nov 4, 2026

Cite this page

510(k) Report. “K914577: Rhythmscan Precision 6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K914577

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026