PMA · Approved

Recalled · 2009

Simpson-Robert Coronary Balloon Dilatation Cathete

P810046PMAApproved Mar 3, 1982173-day reviewClass II21 CFR 870.5100Recalls 4

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

Advanced Cardiovascular Systems, Inc. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

Approved on Mar 3, 1982 through premarket approval, which rests on the device’s own clinical evidence after a 173-day review. 18 later devices descend from it. It has been recalled 4 times.

Decided: Mar 3, 1982
Review: 173 days
Class: Class II
Product code: LOX
Recalls: 4

18 later devices descend from it, 5 citing it directly.

This deviceP810046 Simpson-Robert Coronary Balloon Dilatation CatheteAdvanced Cardiovascular Systems, Inc. · 1982
Descendant · cites it directly · 11 of its ownK103808 Sapphire NCOrbusneich Medical, Inc. · 2011
Descendant · 2 generations on · 9 of its ownK162209 Sapphire NC PlusOrbusneich Medical, Inc. · 2016
Descendant · cites it directly · 5 of its ownK103657 SapphireOrbusneich Medical, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK163114 Sapphire II PROOrbusneich Medical, Inc. · 2017
Descendant · 3 generations on · 3 of its ownK192344 Sapphire NC Plus Coronary Dilatation CatheterOrbusneich Medical Trading, Inc. · 2019

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2011high 4 (2021) · low 0 (2012)2026

Most influential descendants

Showing 5 of 18 · See all

K103808Sapphire NCOrbusneich Medical, Inc. · 2011 · cites it directly11descendants
K162209Sapphire NC PlusOrbusneich Medical, Inc. · 2016 · 2 generations on9descendants
K103657SapphireOrbusneich Medical, Inc. · 2011 · cites it directly5descendants
K163114Sapphire II PROOrbusneich Medical, Inc. · 2017 · 2 generations on4descendants
K192344Sapphire NC Plus Coronary Dilatation CatheterOrbusneich Medical Trading, Inc. · 2019 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	P810046	Simpson-Robert Coronary Balloon Dilatation Cathete	Advanced Cardiovascular Systems, Inc.	1982	—
+1	K103808	Sapphire NC	Orbusneich Medical, Inc.	2011	—
+2	K162209	Sapphire NC Plus	Orbusneich Medical, Inc.	2016	—
+1	K103657	Sapphire	Orbusneich Medical, Inc.	2011	—
+2	K163114	Sapphire II PRO	Orbusneich Medical, Inc.	2017	—
+3	K192344	Sapphire NC Plus Coronary Dilatation Catheter	Orbusneich Medical Trading, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2014	2	0
2016	2	0
2017	1	0
2018	2	0
2019	1	0
2021	4	0
2023	2	0
2024	2	0

FIG. 1 — Lineage of P810046, 1982–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LOX? 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 LOX device

#1 K254022 FLASH Flex™ Aorto-Ostial Angioplasty Systemscore 12.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K103808	Sapphire NC	Orbusneich Medical, Inc.	2011	11
K103657	Sapphire	Orbusneich Medical, Inc.	2011	5
K133852	Apollo Balloon Dilatation Catheter	Brosmed Medical	2014	2
K153742	Apollo Balloon Dilatation Catheter	Brosmed Medical Co., Ltd.	2016	1
K141025	Artimes Balloon Dilatation Catheter	Brosmed Medical	2014	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 17, 2009	Not classified	Z-1804-2009	Process control	Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
Jun 17, 2009	Not classified	Z-1805-2009	Process control	Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
Jun 17, 2009	Not classified	Z-1806-2009	Process control	Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
Jun 17, 2009	Not classified	Z-1807-2009	Process control	Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K103808 (Orbusneich Medical, Inc., 2011) has gone furthest, with 11 descendants of its own.

How does its category compare?

All LOX devices

LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LOX

4in 2024

2007high 32 (2010) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOX

241in 2024

2007high 241 (2024) · low 80 (2018)2026

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

Recalls per year · LOX

4in 2019

2007high 80 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LOX

1,890in 2025

2007high 2,753 (2017) · low 1,053 (2007)2025

MAUDE reports naming product code LOX, 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	19	—	1	1,053
2008	22	—	80	1,063
2009	28	—	0	1,353
2010	32	—	0	1,392
2011	9	103	0	2,090
2012	10	120	0	2,092
2013	6	123	0	2,436
2014	6	166	0	2,316
2015	4	119	0	2,060
2016	9	116	0	2,578
2017	6	113	0	2,753
2018	7	80	0	2,225
2019	1	—	4	2,102
2020	1	—	0	1,974
2021	6	167	0	1,738
2022	5	121	0	1,816
2023	4	138	0	1,720
2024	4	241	0	1,804
2025	0	—	0	1,890
2026	6	156	0	—

https://510kreport.com/device/P810046 · printed Nov 6, 2026

Cite this page

510(k) Report. “P810046: Simpson-Robert Coronary Balloon Dilatation Cathete.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P810046

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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