510(k) · Cleared

Cleared

Reprocessed Electrophysiology Catheter

K030279510(k) TraditionalCleared Oct 3, 2003249-day reviewClass II21 CFR 870.1220

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

Alliance Medical Corp. · NLH Catheter, Recording, Electrode, Reprocessed

Cleared on Oct 3, 2003 as substantially equivalent to K931794 (Medtronic Cardiorhythm, 1994) and 2 other predicates after a 249-day review. Its family tree reaches back 1 generation to 1994.

Decided: Oct 3, 2003
Review: 249 days
Class: Class II
Product code: NLH
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K931794 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
This deviceK030279 Reprocessed Electrophysiology CatheterAlliance Medical Corp. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931794	Marinr Series EP Diagnostic Catheters	Medtronic Cardiorhythm	1994	—
0 (this device)	K030279	Reprocessed Electrophysiology Catheter	Alliance Medical Corp.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1998	1	0

FIG. 1 — Lineage of K030279, 1994–2003Source: 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 NLH? 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 NLH device

#1 K252405 Medline ReNewal Reprocessed Boston Scientific…score 10.4 · 1 generation · 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? (3)

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
*	K931794	Marinr Series EP Diagnostic Catheters Summary page 5 …Catheter Predicate device(s): Legally marketed Electrophysiology Catheter devices under various 51O(k) premarket notifications. K931794 Marinr Series EP Diagnostic Catheters K951347 Marinr Series EP Diagnostic Catheters K981642 Stablemap…	Medtronic Cardiorhythm	1994	—
*	K951347	Marinr Series EP Diagnosti Catheters Summary page 5 …siology Catheter devices under various 51O(k) premarket notifications. K931794 Marinr Series EP Diagnostic Catheters K951347 Marinr Series EP Diagnostic Catheters K981642 Stablemapr Steerable Intracardiac Catheters Device description:…	Medtronic Cardiorhythm	1995	—
*	K981642	Stablemapr Steerable Intracardiac Catheters Summary page 5 …us 51O(k) premarket notifications. K931794 Marinr Series EP Diagnostic Catheters K951347 Marinr Series EP Diagnostic Catheters K981642 Stablemapr Steerable Intracardiac Catheters Device description: Diagnostic electrophysiology (EP) catheters are specially…	Medtronic Cardiorhythm	1998	—

Also cleared against K931794: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 3 ancestors has a recall.
6 other devices also cite its predicate K931794.

How does its category compare?

All NLH devices

NLH Catheter, Recording, Electrode, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NLH

2in 2025

2007high 11 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NLH

165in 2024

2007high 195 (2019) · low 120 (2010)2026

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

Recalls per year · NLH

28so far in 2026, the most since 2007

2007high 28 (2026) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NLH

66in 2025

2007high 66 (2025) · low 0 (2008)2025

MAUDE reports naming product code NLH, 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	0	—	0	1
2008	2	—	1	0
2009	1	—	0	1
2010	3	120	0	8
2011	2	—	0	10
2012	1	—	0	9
2013	0	—	1	6
2014	0	—	0	17
2015	1	—	0	34
2016	11	133	3	25
2017	4	138	0	11
2018	4	122	4	21
2019	4	195	0	38
2020	2	—	0	28
2021	2	—	0	55
2022	1	—	0	12
2023	1	—	0	30
2024	6	165	0	47
2025	2	—	0	66
2026	0	—	28 (1)	—

What is it indicated for?

Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

Reprocessed electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.

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/K030279 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030279: Reprocessed Electrophysiology Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030279

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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