510(k) · Cleared

Cleared

Syneflash & Syneview

K990727510(k) TraditionalCleared Nov 26, 1999266-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

Ela Medical, Inc. · DQK Computer, Diagnostic, Programmable

Cleared on Nov 26, 1999 as substantially equivalent to K942565 (Burdick Corp., 1994) and 5 other predicates after a 266-day review. Its family tree reaches back 2 generations to 1987. 68 later devices descend from it.

Decided: Nov 26, 1999
Review: 266 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 6

Its longest line of descent runs back 2 generations to K871344 (1987). 8 ancestors in all. 68 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK871344 Pathfinder 3, Auto Surveyor and SurveyorReynolds Medical, Ltd. · 1987
1 generation backK951902 Pathfinder 700 Holter AnalyzerReynolds Medical, Ltd. · 1996 · Recalled
This deviceK990727 Syneflash & SyneviewEla Medical, Inc. · 1999
Descendant · cites it directly · 56 of its ownK032466 SpiderviewEla Medical, Inc. · 2003
Descendant · 2 generations on · 46 of its ownK042108 Vista PlusNovacor · 2005
Descendant · 3 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
Descendant · 3 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
Descendant · 4 generations on · 28 of its ownK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2003high 6 (2017) · low 0 (2013)2026

Most influential descendants

Showing 5 of 68 · See all

K032466SpiderviewEla Medical, Inc. · 2003 · cites it directly56descendants
K042108Vista PlusNovacor · 2005 · 2 generations on46descendants
K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 3 generations on40descendants
K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 3 generations on30descendants
K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc. · 2008 · 4 generations on28descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K871344	Pathfinder 3, Auto Surveyor and Surveyor	Reynolds Medical, Ltd.	1987	—
−1	K951902	Pathfinder 700 Holter Analyzer	Reynolds Medical, Ltd.	1996	1
0 (this device)	K990727	Syneflash & Syneview	Ela Medical, Inc.	1999	—
+1	K032466	Spiderview	Ela Medical, Inc.	2003	—
+2	K042108	Vista Plus	Novacor	2005	—
+3	K071641	Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…	Medtronic, Inc.	2007	—
+3	K071655	Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)…	Medtronic, Inc.	2007	—
+4	K082475	Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac…	Medtronic, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1994	1	0
1995	3	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	1	0
2005	2	0
2006	1	0
2007	4	0
2008	1	0
2009	2	0
2010	2	0
2011	2	0
2012	1	0
2014	4	0
2015	5	0
2016	5	0
2017	6	0
2018	1	0
2019	4	0
2020	5	0
2021	4	0
2022	3	0
2023	6	0
2024	1	0
2025	2	0
2026	4	0

FIG. 1 — Lineage of K990727, 1987–2026Source: 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 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? (6)

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
*	K942565	Altair-Disc Recorder Summary page 1 …. Goble 510(k) Number: K990727 Date of Judgment of Substantial Equivalence Sent to Applicant; Predicate Devices: For Syneflash™: BURDICK ALTAIR Disc recorder (510(k) K942565, Burdick Inc.), BRAEMAR DL700 (510(k) K945130, Braemar Inc.) and OXFORD MEDILOG FD4 (510(k) K970902, Oxford Instruments). For Sy…	Burdick Corp.	1994	—
*	K945130	Braemar Model DL700 Ambulatory Electrocardiographic Recorder Summary page 1 …ent of Substantial Equivalence Sent to Applicant; Predicate Devices: For Syneflash™: BURDICK ALTAIR Disc recorder (510(k) K942565, Burdick Inc.), BRAEMAR DL700 (510(k) K945130, Braemar Inc.) and OXFORD MEDILOG FD4 (510(k) K970902, Oxford Instruments). For Syneview™: El.A Medical ELATEC (510(k) K895806,…	Braemar Corp.	1995	—
*	K970902	Medilog FD4 Summary page 1 …dicate Devices: For Syneflash™: BURDICK ALTAIR Disc recorder (510(k) K942565, Burdick Inc.), BRAEMAR DL700 (510(k) K945130, Braemar Inc.) and OXFORD MEDILOG FD4 (510(k) K970902, Oxford Instruments). For Syneview™: El.A Medical ELATEC (510(k) K895806, ELA Medical Inc.), BURDICK ALTAIR 8200 (510(k) K945985…	Oxford Instruments Medical Systems	1997	—
*	K895806	Elatec Holter Analyzer Summary page 1 …565, Burdick Inc.), BRAEMAR DL700 (510(k) K945130, Braemar Inc.) and OXFORD MEDILOG FD4 (510(k) K970902, Oxford Instruments). For Syneview™: El.A Medical ELATEC (510(k) K895806, ELA Medical Inc.), BURDICK ALTAIR 8200 (510(k) K945985, Burdick Inc.) and REYNOLDS Pathfinder 700 (510(k) K951902, Reynolds Medi…	Ela Medical, Inc.	1990	—
*	K945985	PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400 Summary page 1 …ar Inc.) and OXFORD MEDILOG FD4 (510(k) K970902, Oxford Instruments). For Syneview™: El.A Medical ELATEC (510(k) K895806, ELA Medical Inc.), BURDICK ALTAIR 8200 (510(k) K945985, Burdick Inc.) and REYNOLDS Pathfinder 700 (510(k) K951902, Reynolds Medical Ltd.). 2.1.2 Description of Conditions for Which th…	Burdick, Inc.	1995	—
*	K951902	Pathfinder 700 Holter Analyzer Summary page 1 …truments). For Syneview™: El.A Medical ELATEC (510(k) K895806, ELA Medical Inc.), BURDICK ALTAIR 8200 (510(k) K945985, Burdick Inc.) and REYNOLDS Pathfinder 700 (510(k) K951902, Reynolds Medical Ltd.). 2.1.2 Description of Conditions for Which the Devices are Indicated Generally accepted indications for…	Reynolds Medical, Ltd.	1996	1

Also cleared against K942565: 1 other device →

What descends from it? (68)

See all 68

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

Number	Device	Applicant	Decided	Descendants
K032466	Spiderview	Ela Medical, Inc.	2003	56
K031466	Iqmark Digital Holter	Brentwood Medical Technology Corp.	2003	6
K042002	Synescope, Easyscope, Synecom, Holterreader	Ela Medical, Inc.	2004	3

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?

The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
1 of the 8 ancestors has a recall of any class.
Of its descendants, K032466 (Ela Medical, Inc., 2003) has gone furthest, with 56 descendants of its own.
1 other device also cites its predicate K942565.

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	—

What is it indicated for?

Recording of two- or three-channel surface ECG (Electrocardiogram) data from ambulatory patients during a 24-hour period.

High-resolution recording of surface ECG data.

Analysis of recorded Holter ECG data.

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/K990727 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990727: Syneflash & Syneview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990727

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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