510(k) · Cleared

Cleared

Synetec

K002817510(k) TraditionalCleared May 2, 2001233-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 May 2, 2001 after a 233-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 51 later devices descend from it.

Decided: May 2, 2001
Review: 233 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 0

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

This deviceK002817 SynetecEla Medical, Inc. · 2001
Descendant · cites it directly · 46 of its ownK042108 Vista PlusNovacor · 2005
Descendant · 2 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
Descendant · 2 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
Descendant · 3 generations on · 28 of its ownK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
Descendant · 3 generations on · 26 of its ownK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2004high 6 (2017) · low 0 (2006)2026

Most influential descendants

Showing 5 of 51 · See all

K042108Vista PlusNovacor · 2005 · cites it directly46descendants
K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 2 generations on40descendants
K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 2 generations on30descendants
K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc. · 2008 · 3 generations on28descendants
K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc. · 2011 · 3 generations on26descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002817	Synetec	Ela Medical, Inc.	2001	—
+1	K042108	Vista Plus	Novacor	2005	—
+2	K071641	Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…	Medtronic, Inc.	2007	—
+2	K071655	Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)…	Medtronic, Inc.	2007	—
+3	K082475	Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac…	Medtronic, Inc.	2008	—
+3	K103764	Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable…	Medtronic, Inc.	2011	—

Descendants by year cleared

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

FIG. 1 — Lineage of K002817, 2001–2026Source: 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (51)

See all 51

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

Number	Device	Applicant	Decided	Descendants
K042108	Vista Plus	Novacor	2005	46
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?

Of its descendants, K042108 (Novacor, 2005) has gone furthest, with 46 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/K002817 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002817: Synetec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002817

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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