510(k) · Cleared

Cleared

Numed Ghost II Pta Catheters

K003972510(k) SpecialCleared Jan 11, 200120-day reviewClass II21 CFR 870.1250

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

NuMED, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Jan 11, 2001 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.

Decided: Jan 11, 2001
Review: 20 days
Class: Class II
Product code: LIT
Recalls: None
Predicates: 0

20 later devices descend from it, 3 citing it directly.

This deviceK003972 Numed Ghost II Pta CathetersNuMED, Inc. · 2001
Descendant · cites it directly · 16 of its ownK020854 Modification to Fox Pta CatheterJomed AG · 2002
Descendant · 2 generations on · 8 of its ownK033217 Pheron Pta CatheterBiotronik, Inc. · 2003
Descendant · 3 generations on · 7 of its ownK072765 Passeo 18Biotronik, Inc. · 2007
Descendant · 3 generations on · 5 of its ownK082933 Passeo-35 Pta CatheterBiotronik, Inc. · 2008
Descendant · 2 generations on · 5 of its ownK040954 Fox Plus Pta CatheterAbbott Laboratories, Inc. · 2004

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2002high 3 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 20 · See all

K020854Modification to Fox Pta CatheterJomed AG · 2002 · cites it directly16descendants
K033217Pheron Pta CatheterBiotronik, Inc. · 2003 · 2 generations on8descendants
K072765Passeo 18Biotronik, Inc. · 2007 · 3 generations on7descendants
K082933Passeo-35 Pta CatheterBiotronik, Inc. · 2008 · 3 generations on5descendants
K040954Fox Plus Pta CatheterAbbott Laboratories, Inc. · 2004 · 2 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003972	Numed Ghost II Pta Catheters	NuMED, Inc.	2001	—
+1	K020854	Modification to Fox Pta Catheter	Jomed AG	2002	—
+2	K033217	Pheron Pta Catheter	Biotronik, Inc.	2003	—
+3	K072765	Passeo 18	Biotronik, Inc.	2007	—
+3	K082933	Passeo-35 Pta Catheter	Biotronik, Inc.	2008	—
+2	K040954	Fox Plus Pta Catheter	Abbott Laboratories, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	1	0
2004	2	0
2005	1	0
2006	2	0
2007	2	0
2008	3	0
2013	1	0
2014	1	0
2015	2	0
2016	1	0
2023	1	0
2025	1	0

FIG. 1 — Lineage of K003972, 2001–2025Source: 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 LIT? 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 LIT device

#1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K020854	Modification to Fox Pta Catheter	Jomed AG	2002	16
K040830	Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters	NuMED, Inc.	2004	1
K021996	Bolton Pta Catheter	Bolton Medical, Inc.	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, K020854 (Jomed AG, 2002) has gone furthest, with 16 descendants of its own.

How does its category compare?

All LIT devices

LIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LIT

3in 2025

2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007high 205 (2026) · low 29 (2009)2026

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

Recalls per year · LIT

1in 2025

2007high 3 (2014) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LIT

2,073in 2025

2007high 2,492 (2021) · low 513 (2008)2025

MAUDE reports naming product code LIT, 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	6	64	0	577
2008	8	53	0	513
2009	7	29	2	623
2010	13	78	1	809
2011	10	82	0	857
2012	19	29	0	1,277
2013	14	79	2 (2)	1,242
2014	12	90	3	1,178
2015	19	112	0	1,279
2016	11	116	1	1,529
2017	9	57	0	2,081
2018	6	118	2	2,188
2019	4	40	3	2,405
2020	9	125	0	2,443
2021	4	61	1	2,492
2022	8	122	0	2,155
2023	6	167	0	1,807
2024	6	43	2	1,913
2025	3	90	1	2,073
2026	4	205	0	—

https://510kreport.com/device/K003972 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003972: Numed Ghost II Pta Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003972

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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