510(k) · Cleared

Cleared

Ambulatory (Holter) Recording System

K950944510(k) TraditionalCleared Jun 18, 1996487-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

Biosensor Corp. · DQK Computer, Diagnostic, Programmable

Cleared on Jun 18, 1996 after a 487-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 105 later devices descend from it.

Decided: Jun 18, 1996
Review: 487 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 0

105 later devices descend from it, 4 citing it directly.

This deviceK950944 Ambulatory (Holter) Recording SystemBiosensor Corp. · 1996
Descendant · cites it directly · 62 of its ownK993617 Digitrakplus Holter RecorderBraemar Corp. · 1999
Descendant · 2 generations on · 56 of its ownK032466 SpiderviewEla Medical, Inc. · 2003
Descendant · 2 generations on · 46 of its ownK042108 Vista PlusNovacor · 2005
Descendant · cites it directly · 43 of its ownK993618 DXP1000 Holter RecorderBraemar Corp. · 1999
Descendant · 3 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007

Showing 5 of 105 descendants. See all descendants

Descendants cleared per year

1999high 10 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 105 · See all

K993617Digitrakplus Holter RecorderBraemar Corp. · 1999 · cites it directly62descendants
K032466SpiderviewEla Medical, Inc. · 2003 · 2 generations on56descendants
K042108Vista PlusNovacor · 2005 · 2 generations on46descendants
K993618DXP1000 Holter RecorderBraemar Corp. · 1999 · cites it directly43descendants
K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 3 generations on40descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K950944	Ambulatory (Holter) Recording System	Biosensor Corp.	1996	—
+1	K993617	Digitrakplus Holter Recorder	Braemar Corp.	1999	—
+2	K032466	Spiderview	Ela Medical, Inc.	2003	—
+2	K042108	Vista Plus	Novacor	2005	—
+1	K993618	DXP1000 Holter Recorder	Braemar Corp.	1999	—
+3	K071641	Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…	Medtronic, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	2	0
2002	1	0
2003	4	0
2005	2	0
2006	1	0
2007	5	0
2008	1	0
2009	2	0
2010	4	0
2011	8	0
2012	2	0
2013	2	0
2014	5	0
2015	4	0
2016	6	0
2017	7	0
2018	3	0
2019	4	0
2020	6	0
2021	5	0
2022	6	0
2023	10	0
2024	3	0
2025	3	0
2026	9	0

FIG. 1 — Lineage of K950944, 1996–2026Source: 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 26.6 · 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? (105)

See all 105

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

Number	Device	Applicant	Decided	Descendants
K993617	Digitrakplus Holter Recorder	Braemar Corp.	1999	62
K993618	DXP1000 Holter Recorder	Braemar Corp.	1999	43
K030856	ER800 Series Ecg Event Recorder	Braemar Corp.	2003	6
K012825	Hearttrends	Lev-El, Ltd.	2002	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, K993617 (Braemar Corp., 1999) has gone furthest, with 62 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/K950944 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950944: Ambulatory (Holter) Recording System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950944

Report an extraction error

Are you the manufacturer?

Record history

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