510(k) · Cleared

Cleared

Scimed Informer Pressure Wire System

K974241510(k) TraditionalCleared Nov 12, 1998365-day reviewClass II21 CFR 870.1330

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

Scimed Life Systems, Inc. · DQX Wire, Guide, Catheter

Cleared on Nov 12, 1998 as substantially equivalent to K943192 (Scimed Life Systems, Inc., 1994) and 14 other predicates after a 365-day review. Its family tree reaches back 3 generations to 1994.

Decided: Nov 12, 1998
Review: 365 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 15

Its longest line of descent runs back 3 generations to K941895 (1994). 34 ancestors in all, the oldest K823434 (1982). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK941895 Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic CoatingScimed Life Systems, Inc. · 1994
2 generations backK962572 Scimed Choice PT Vision Ptca Guide WireScimed Life Systems, Inc. · 1996 · Recalled
1 generation backK965023 Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide WireScimed Life Systems, Inc. · 1997
This deviceK974241 Scimed Informer Pressure Wire SystemScimed Life Systems, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K941895	Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating	Scimed Life Systems, Inc.	1994	—
−2	K962572	Scimed Choice PT Vision Ptca Guide Wire	Scimed Life Systems, Inc.	1996	3
−1	K965023	Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide Wire	Scimed Life Systems, Inc.	1997	—
0 (this device)	K974241	Scimed Informer Pressure Wire System	Scimed Life Systems, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1986	1	0
1991	2	0
1992	2	0
1993	3	0
1994	7	0
1995	8	0
1996	5	0
1997	2	0

FIG. 1 — Lineage of K974241, 1994–1998Source: 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 DQX? 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 DQX device

#1 K213854 SavvyWirescore 15.7 · 10 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? (15)

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
*	K943192	Scimed Choice (TM) Ptca Guide Wire Summary page 3 …ices. K974241 Amendment SCIMED® Informer™ Pressure Wire System Summary of Safety and Effectiveness, continued Predicate 10(k Devices, CholCE Guide Wire K943192 November 22, 1994 continued K945129 March 3, 1995 K950141 March 3, 1995 K950113 March 31, 1995 K961015 May 15, 1996 K965063 March…	Scimed Life Systems, Inc.	1994	—
*	K945129	Scimed Chioce Plus Ptca Guide Wire Summary page 3 …ent SCIMED® Informer™ Pressure Wire System Summary of Safety and Effectiveness, continued Predicate 10(k Devices, CholCE Guide Wire K943192 November 22, 1994 continued K945129 March 3, 1995 K950141 March 3, 1995 K950113 March 31, 1995 K961015 May 15, 1996 K965063 March 4, 1997 K964551 May 21, 1997 Scepto…	Scimed Life Systems, Inc.	1995	—
*	K950141	Scimed (R) Choice (TM) Ptca Guide Wire Summary page 3 …Pressure Wire System Summary of Safety and Effectiveness, continued Predicate 10(k Devices, CholCE Guide Wire K943192 November 22, 1994 continued K945129 March 3, 1995 K950141 March 3, 1995 K950113 March 31, 1995 K961015 May 15, 1996 K965063 March 4, 1997 K964551 May 21, 1997 Sceptor Guide Wire K942333 A…	Scimed Life Systems, Inc.	1995	—
*	K950113	Scimed (R) Chice (TM) Exchange Ptca Guide Wire Summary page 3 …Summary of Safety and Effectiveness, continued Predicate 10(k Devices, CholCE Guide Wire K943192 November 22, 1994 continued K945129 March 3, 1995 K950141 March 3, 1995 K950113 March 31, 1995 K961015 May 15, 1996 K965063 March 4, 1997 K964551 May 21, 1997 Sceptor Guide Wire K942333 August 31, 1994 K946240…	Scimed Life Systems, Inc.	1995	—
*	K961015	Scimed Choice/Ptca Guide Wire/Plus Ptca Guide Wire/Exchange Ptca Guide Wire Summary page 3 …ffectiveness, continued Predicate 10(k Devices, CholCE Guide Wire K943192 November 22, 1994 continued K945129 March 3, 1995 K950141 March 3, 1995 K950113 March 31, 1995 K961015 May 15, 1996 K965063 March 4, 1997 K964551 May 21, 1997 Sceptor Guide Wire K942333 August 31, 1994 K946240 March 31, 1995 K950534…	Scimed Life Systems, Inc.	1996	—
*	K965023	Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide Wire Our OCR of the scanned summary read K965063, FDA’s number for Audiotone (a-552) (Miracle-Ear, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CholCE Guide Wire”.	Scimed Life Systems, Inc.	1997	—
*	K964551	Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice… Summary page 3 …ices, CholCE Guide Wire K943192 November 22, 1994 continued K945129 March 3, 1995 K950141 March 3, 1995 K950113 March 31, 1995 K961015 May 15, 1996 K965063 March 4, 1997 K964551 May 21, 1997 Sceptor Guide Wire K942333 August 31, 1994 K946240 March 31, 1995 K950534 April 28, 1995 K960563 April 29, 1996 Nami…	Scimed Life Systems, Inc.	1997	—
*	K942333	Scimed EN Tre' Iii Ptca Guide Wire Summary page 3 …22, 1994 continued K945129 March 3, 1995 K950141 March 3, 1995 K950113 March 31, 1995 K961015 May 15, 1996 K965063 March 4, 1997 K964551 May 21, 1997 Sceptor Guide Wire K942333 August 31, 1994 K946240 March 31, 1995 K950534 April 28, 1995 K960563 April 29, 1996 Namic Perceptor DT K910764 April 22, 1991 Di…	Scimed Life Systems, Inc.	1994	—
*	K946240	Scimed (R) Sceptor (TM) Ptca Guide Wire Summary page 3 …129 March 3, 1995 K950141 March 3, 1995 K950113 March 31, 1995 K961015 May 15, 1996 K965063 March 4, 1997 K964551 May 21, 1997 Sceptor Guide Wire K942333 August 31, 1994 K946240 March 31, 1995 K950534 April 28, 1995 K960563 April 29, 1996 Namic Perceptor DT K910764 April 22, 1991 Disposable Transducer Mede…	Scimed Life Systems, Inc.	1995	—
*	K950534	Scimed Sceptor Ptca Guide Wire Summary page 3 …41 March 3, 1995 K950113 March 31, 1995 K961015 May 15, 1996 K965063 March 4, 1997 K964551 May 21, 1997 Sceptor Guide Wire K942333 August 31, 1994 K946240 March 31, 1995 K950534 April 28, 1995 K960563 April 29, 1996 Namic Perceptor DT K910764 April 22, 1991 Disposable Transducer Medex TranStar K942377 Augu…	Scimed Life Systems, Inc.	1995	—
*	K960563	Scimed Sceptor & Sceptor Exchange Ptca Guide Wires Summary page 3 …3 March 31, 1995 K961015 May 15, 1996 K965063 March 4, 1997 K964551 May 21, 1997 Sceptor Guide Wire K942333 August 31, 1994 K946240 March 31, 1995 K950534 April 28, 1995 K960563 April 29, 1996 Namic Perceptor DT K910764 April 22, 1991 Disposable Transducer Medex TranStar K942377 August 16, 1994 Pressure Tr…	Scimed Life Systems, Inc.	1996	—
*	K910764	The Perceptor (TM) Stand Alone Transducer Summary page 3 …063 March 4, 1997 K964551 May 21, 1997 Sceptor Guide Wire K942333 August 31, 1994 K946240 March 31, 1995 K950534 April 28, 1995 K960563 April 29, 1996 Namic Perceptor DT K910764 April 22, 1991 Disposable Transducer Medex TranStar K942377 August 16, 1994 Pressure Transducer Baxter Edwards K925638 October 18…	North American Instrument Corp.	1991	1
*	K942377	Transtar Pressure Transducer Summary page 3 …42333 August 31, 1994 K946240 March 31, 1995 K950534 April 28, 1995 K960563 April 29, 1996 Namic Perceptor DT K910764 April 22, 1991 Disposable Transducer Medex TranStar K942377 August 16, 1994 Pressure Transducer Baxter Edwards K925638 October 18, 1993 Reusable PX-1800 Cardiometrics K965140 August 18, 199…	Medex, Inc.	1994	3
*	K925638	Phoenix Disposable Pressure Transducer #73-600 Summary page 3 …28, 1995 K960563 April 29, 1996 Namic Perceptor DT K910764 April 22, 1991 Disposable Transducer Medex TranStar K942377 August 16, 1994 Pressure Transducer Baxter Edwards K925638 October 18, 1993 Reusable PX-1800 Cardiometrics K965140 August 18, 1997 WaveWire/WaveMap Pressure System Device The SCIMED® Infor…	Baxter Healthcare Corp	1993	1
*	K965140	Cardiometrics Wavewire/Wavemap Pressure System Summary page 3 …64 April 22, 1991 Disposable Transducer Medex TranStar K942377 August 16, 1994 Pressure Transducer Baxter Edwards K925638 October 18, 1993 Reusable PX-1800 Cardiometrics K965140 August 18, 1997 WaveWire/WaveMap Pressure System Device The SCIMED® Informer™ Pressure Wire System consists of the Description fo…	Cardio Metrics, Inc.	1997	—

Also cleared against K943192: 4 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?

The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
5 of the 34 ancestors have a recall of any class.
4 other devices also cite its predicate K943192.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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	14	85	12	760
2008	19	87	7	715
2009	18	87	49	687
2010	21	63	34	987
2011	18	43	3	1,311
2012	20	62	5	1,337
2013	18	119	7 (4)	1,474
2014	18	103	0	1,323
2015	15	112	1	1,323
2016	14	179	2 (2)	1,466
2017	19	85	17	1,524
2018	19	114	9	1,737
2019	13	173	2	1,679
2020	14	106	1 (1)	1,536
2021	6	161	0	1,713
2022	15	212	0	1,647
2023	10	136	0	2,068
2024	11	134	3	2,210
2025	10	177	0	2,178
2026	12	145	4 (1)	—

What is it indicated for?

The SCIMED Informer™ Pressure Wire System is intended to monitor the mean intravascular blood pressure and to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The phasic wave signal of the INFORMER Pressure Wire System is intended to facilitate placement of the wire. The INFORMER Pressure Wire is not intended for use in the cerebral vasculature. The SCIMED…

Read the full statement (119 words)

The SCIMED INFORMER Pressure Wire System is not intended to be used in combination with any H.F. surgical equipment.

The SCIMED INFORMER Pressure Wire System is indicated for use with all physiological monitors that meet IEC 601-1, IEC 601-2-34 standards. These monitors are required to meet electrical isolation for Type CF applied parts.

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/K974241 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974241: Scimed Informer Pressure Wire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974241

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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