510(k) Report

510(k) · Cleared

Cleared

Response (TM) Steerable Catheter

K913940510(k) TraditionalCleared Jan 26, 1993511-day reviewClass II21 CFR 870.1280

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

Daig Corp. · DRA Catheter, Steerable

Cleared on Jan 26, 1993 after a 511-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 of the 17 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.

Decided
Jan 26, 1993
Review
511 days
Class
Class II
Product code
DRA
Recalls
None
Predicates
0

16 later devices descend from it, 4 citing it directly. 7 of the 17 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2015: 2 descendants cleared2003: 1 descendant cleared2010: 1 descendant cleared2016: 1 descendant cleared2019: 3 descendants cleared, 1 with a Class I recall12024: 3 descendants cleared, 3 with a Class I recall32023: 2 descendants cleared, 2 with a Class I recall22025: 1 descendant cleared, 1 with a Class I recall12026: 2 descendants cleared1990200020102020
  1. This deviceK913940 Response (TM) Steerable CatheterDaig Corp. · 1993
  2. Descendant · cites it directly · 14 of its ownK102721 Livewire Electophysiology CatheterSt Jude Medical · 2010
  3. Descendant · cites it directly · 12 of its ownK150631 St. Jude Medical MediGuide Enabled Livewire Steerable…St Jude Medical · 2015
  4. Descendant · cites it directly · 11 of its ownK151622 St.Jude Medical MediGuide Enabled Livewire Steerable…St Jude Medical · 2015
  5. Descendant · 2 generations on · 6 of its ownK190106 Intra-Operative Positioning System; Simple Curve Catheter, Reverse…Centerline Biomedical, Inc. · 2019 · Recalled (Class I)
  6. Descendant · 3 generations on · 5 of its ownK230309 Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve…Centerline Biomedical, Inc. · 2023 · Recalled (Class I)

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2003: 12010: 12015: 22016: 12019: 32023: 22024: 32025: 12026: 2
2003high 3 (2019) · low 0 (2004)2026

Class I recalls in this family

  • K241156 Medline ReNewal Reprocessed St. Jude Medical…2 generations on · 2024
  • K190106 Intra-Operative Positioning System; Simple Curve…2 generations on · 2019
  • K221067 Medline ReNewal Reprocessed St. Jude Medical…2 generations on · 2023
  • K242133 Intra-Operative Positioning System (IOPS®)…3 generations on · 2024

Most influential descendants

Showing 5 of 16 · See all
  • K102721Livewire Electophysiology CatheterSt Jude Medical · 2010 · cites it directly14descendants
  • K150631St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter…St Jude Medical · 2015 · cites it directly12descendants
  • K151622St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter…St Jude Medical · 2015 · cites it directly11descendants
  • K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc. · 2019 · 2 generations on6descendants
  • K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc. · 2023 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913940Response (TM) Steerable CatheterDaig Corp.1993—
+1K102721Livewire Electophysiology CatheterSt Jude Medical2010—
+1K150631St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology…St Jude Medical2015—
+1K151622St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology…St Jude Medical2015—
+2K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve…Centerline Biomedical, Inc.2019Class I
+3K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter…Centerline Biomedical, Inc.2023Class I

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201010
201520
201610
201931
202322
202433
202511
202620
FIG. 1 — Lineage of K913940, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

7 devices in this family have a Class I recall. 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 DRA device

  1. #1 K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)score 13.2 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K102721Livewire Electophysiology CatheterSt Jude Medical201014
K150631St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter…St Jude Medical201512
K151622St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter…St Jude Medical201511
K030026Reprocessed Electrophysiology CatheterAlliance Medical Corp.20030

Has anything in its family been recalled? (7 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K241156Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology…Surgical Instrument Service and Savings, Inc. · 2024 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls
  • K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
  • K221067Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterSurgical Instrument Service and Savings, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
  • K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
  • K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
  • K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
  • K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 3 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

Nearest 5 of 7; all are on the web page.

What does this lineage say?

  • Of its descendants, K102721 (St Jude Medical, 2010) has gone furthest, with 14 descendants of its own.

How does its category compare?

All DRA devices

DRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRA

1in 2025

2007: 12008: 12009: 22010: 32011: 12012: 42014: 12015: 12016: 42017: 22018: 12019: 22020: 12021: 12022: 22023: 32025: 12026 (partial year): 1
2007high 4 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRA

89in 2023

2010: 29 days median2012: 70 days median2016: 123 days median2023: 89 days median
2007high 123 (2016) · low 29 (2010)2026

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

Recalls per year · DRA

4so far in 2026, the most since 2007

2008: 12011: 12026 (partial year): 4
2007high 4 (2026) · low 0 (2007)2026

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

Adverse event reports per year · DRA

4,018in 2025

2007: 62008: 232009: 52010: 22011: 1552012: 892013: 1132014: 2122015: 3502016: 4812017: 6252018: 6332019: 7002020: 7032021: 7412022: 6522023: 7882024: 1,9622025: 4,018
2007high 4,018 (2025) · low 2 (2010)2025

MAUDE reports naming product code DRA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—06
20081—123
20092—05
201032902
20111—1155
2012470089
20130—0113
20141—0212
20151—0350
201641230481
20172—0625
20181—0633
20192—0700
20201—0703
20211—0741
20222—0652
20233890788
20240—01,962
20251—04,018
20261—4—

More from Daig Corp.

63 FDA decisions under this applicant name. See the company

  • K000004Alliance Left Heart Delivery System Introducer, Model #407509Daig Corp. · 2000
  • K994334Ultra-Flex Hemostasis Introducer. Model 406XXXDaig Corp. · 2000
  • K982299Spyglass 5 FR Angiographic CatheterDaig Corp. · 1998
  • K982187Fast-Cath Intra-Cardiac IntroducerDaig Corp. · 19982 recalls
  • K973840Fast-Cath (TM) Intra-Cardiac IntroducerDaig Corp. · 19982 recalls

Recent decisions in DRA

The DRA category page

  • K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation · 2026
  • K250529Globe Introducer (601-01001)Kardium, Inc. · 2025
  • K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation · 20233 recalls
  • K232321FlexCath Contour™ Steerable SheathMedtronic, Inc. · 2023
  • K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter…Boston Scientific Corporation · 20231 Class I recall

https://510kreport.com/device/K913940 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913940: Response (TM) Steerable Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913940

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026