510(k) Report

510(k) · Cleared

Cleared

Intravascular Retrieval Device

K981061510(k) TraditionalCleared May 26, 199864-day reviewClass I21 CFR 878.4200

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

Med Institute, Inc. · GCC Dilator, Catheter

Cleared on May 26, 1998 as substantially equivalent to K945586 (Med Institute, Inc., 1997) and 1 other predicate after a 64-day review. Its family tree reaches back 1 generation to 1997.

Decided
May 26, 1998
Review
64 days
Class
Class I
Product code
GCC
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K945586 (1997). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestorK945586 · Flexible Dilating Sheath · Med Institute, Inc. · 1997199619982000
Other ancestors, by generation 1 generation back: 1 other ancestor K945586 · Flexible Dilating Sheath · Med Institute, Inc. · 19970
  1. Root · 1 generation backK945586 Flexible Dilating SheathMed Institute, Inc. · 1997
  2. This deviceK981061 Intravascular Retrieval DeviceMed Institute, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K945586Flexible Dilating SheathMed Institute, Inc.1997—
0 (this device)K981061Intravascular Retrieval DeviceMed Institute, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K981061, 1997–1998Source: 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 GCC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (2)

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
*K945586Flexible Dilating Sheath
Summary page 1
…ac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects. ‘ Predicate Devices DC# Metal Reinforced Flexible Dilator Sheath K945586 Wilkoff Locking Stylet K970690 Substantial Equivalence: The 510(k) submission serves to notify FDA of labeling revisions made to…
Med Institute, Inc.1997—
*K970690Locking Stylet 2
Summary page 1
…fragments of catheter tubing or wire guides, and other foreign objects. ‘ Predicate Devices DC# Metal Reinforced Flexible Dilator Sheath K945586 Wilkoff Locking Stylet K970690 Substantial Equivalence: The 510(k) submission serves to notify FDA of labeling revisions made to previously cleared devices. No…
Cook Pacemaker Corp.1997—

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All GCC devices

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

FDA decisions per year · GCC

FDA has decided no GCC device since 2007.

Median 510(k) review, days · GCC

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

Recalls per year · GCC

5in 2013

2013: 5
2007high 5 (2013) · low 0 (2007)2026

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

Adverse event reports per year · GCC

4in 2025

2008: 12009: 82014: 12015: 12016: 12017: 32018: 32019: 62020: 32021: 22022: 22023: 22024: 72025: 4
2007high 8 (2009) · low 0 (2007)2025

MAUDE reports naming product code GCC, 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
20080—01
20090—08
20100—00
20110—00
20120—00
20130—50
20140—01
20150—01
20160—01
20170—03
20180—03
20190—06
20200—03
20210—02
20220—02
20230—02
20240—07
20250—04
20260—0—

What is it indicated for?

The Byrd Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The Byrd Stainless Steel Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The Byrd WORK STATION™ is intended for use in patients requiring the percutaneous retrieval of…

Read the full statement (139 words)

The Byrd Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The Byrd Stainless Steel Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The Byrd WORK STATION™ is intended for use in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects.

The Byrd Telescoping Stainless Steel Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The NEEDLE’S EYE™ Snare is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides, and other foreign objects.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Med Institute, Inc.

26 FDA decisions under this applicant name. See the company

  • K990034Wilson-Cook Colonic Z-StentMed Institute, Inc. · 2000
  • K982507Mini Polyurethane CatheterMed Institute, Inc. · 1998
  • K964001Swartz Doppler Flow Probe and Monitor SystemMed Institute, Inc. · 1998
  • K971140Vital-Port Infusion PalMed Institute, Inc. · 1997
  • K970442Target Vital-Port Vascular Access SystemMed Institute, Inc. · 1997

Recent decisions in GCC

The GCC category page

  • K922354Byrd Telescoping Stainless Steel Dilat Sheath SetMed Institute, Inc. · 1992
  • K902502Byrd Stainless Steel DilatorMedical Engineering and Development Institute · 1990
  • K893480Byrd Extractor SetMedical Engineering and Development Institute · 1989
  • K820865Van-Tec Fascial DilatorVan-Tec, Inc. · 1982

https://510kreport.com/device/K981061 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981061: Intravascular Retrieval Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981061

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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