510(k) Report

510(k) · Cleared

Cleared

Steerable Stylet

K040001510(k) TraditionalCleared Mar 9, 200467-day reviewClass II21 CFR 870.1380

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

Synovis Surgical Innovations · DRB Stylet, Catheter

Cleared on Mar 9, 2004 as substantially equivalent to K972814 (Pacesetter, Inc., 1998) after a 67-day review. Its family tree reaches back 1 generation to 1998.

Decided
Mar 9, 2004
Review
67 days
Class
Class II
Product code
DRB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K972814 (1998). No later device cites it as a predicate yet.

K972814 · Locator Model 4036 · Pacesetter, Inc. · 1998199619982000200220042006
K972814 · Locator Model 4036 · Pacesetter, Inc. · 19980
  1. Root · 1 generation backK972814 Locator Model 4036Pacesetter, Inc. · 1998
  2. This deviceK040001 Steerable StyletSynovis Surgical Innovations · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K972814Locator Model 4036Pacesetter, Inc.1998—
0 (this device)K040001Steerable StyletSynovis Surgical Innovations2004—
FIG. 1 — Lineage of K040001, 1998–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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 DRB? 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 DRB device

  1. #1 K220280 Arrow Stiffening Styletscore 5.1 · 5 generations · no Class I recall
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K972814Locator Model 4036
Summary page 1
…ame Catheter Stylet 870.1380 Predicate device The Locator Steerable Stylet, Model 4036 K972814 St. Jude Medical Device Description The Steerable Stylet is a sterile, single-use, dispo…
Pacesetter, Inc.1998—

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?

  • Its one ancestor has no recall.

How does its category compare?

All DRB devices

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

FDA decisions per year · DRB

1in 2022

2008: 22009: 12014: 12017: 12019: 22022: 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRB

Too few DRB 510(k)s in any year since 2007 to give a median.

Recalls per year · DRB

No recall names DRB since 2007.

Adverse event reports per year · DRB

152in 2025

2008: 52009: 42010: 542011: 282012: 402013: 532014: 672015: 662016: 562017: 632018: 402019: 822020: 922021: 972022: 942023: 822024: 1162025: 152
2007high 152 (2025) · low 0 (2007)2025

MAUDE reports naming product code DRB, 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
20070—00
20082—05
20091—04
20100—054
20110—028
20120—040
20130—053
20141—067
20150—066
20160—056
20171—063
20180—040
20192—082
20200—092
20210—097
20221—094
20230—082
20240—0116
20250—0152
20260—0—

What is it indicated for?

The Steerable Stylet is intended to allow the physician to define and vary the curvature of the distal end of a compatible pacemaker lead in patients requiring lead implantation for cardiac pacing.

Indications for use as stated in the FDA summary.

More from Synovis Surgical Innovations

15 FDA decisions under this applicant name. See the company

  • K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations · 2013
  • K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations · 2008
  • K062915Veritas Collagen MatrixSynovis Surgical Innovations · 20061 recall
  • K041669Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSynovis Surgical Innovations · 20048 recalls
  • K040415Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line…Synovis Surgical Innovations · 20041 recall

Recent decisions in DRB

The DRB category page

  • K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.) · 2022
  • K191469Biotronik StyletsBiotronik, Inc. · 2019
  • K182660GaltTWSGalt Medical Corp. · 2019
  • K170298Liberator Beacon Tip Locking StyletCook Incorporated · 2017
  • K142116LLD EZSpectranetics, Inc. · 2014

https://510kreport.com/device/K040001 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040001: Steerable Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040001

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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