510(k) Report

510(k) · Cleared

Cleared

Transcervical Intrauterine Kit

K914387510(k) TraditionalCleared Dec 30, 199190-day reviewClass II21 CFR 884.2700

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

Telos Medical Corp. · HGS Catheter, Intrauterine And Introducer

Cleared on Dec 30, 1991 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Dec 30, 1991
Review
90 days
Class
Class II
Product code
HGS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K914387Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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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?

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.

How does its category compare?

All HGS devices

HGS Catheter, Intrauterine And Introducer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HGS

FDA has decided no HGS device since 2007.

Median 510(k) review, days · HGS

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

Recalls per year · HGS

No recall names HGS since 2007.

Adverse event reports per year · HGS

1in 2017

2007: 22008: 22009: 12017: 1
2007high 2 (2007) · low 0 (2010)2025

MAUDE reports naming product code HGS, 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—02
20080—02
20090—01
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Telos Medical Corp.

7 FDA decisions under this applicant name. See the company

  • K920375Disposable Intrauterine Pressure TransducerTelos Medical Corp. · 1992
  • K920044Dual Lumen Transcerivical Intrauterine KitTelos Medical Corp. · 1992
  • K905018Lab-Site Safety NeedleTelos Medical Corp. · 1991
  • K905017Lab-SiteTelos Medical Corp. · 1991
  • K882224Ultrans Disposable IntrauterineTelos Medical Corp. · 1989

Recent decisions in HGS

The HGS category page

  • K905812Intrauterine Catheter SetEpcom Medical Systems, Inc. · 1991

https://510kreport.com/device/K914387 · printed Nov 5, 2026

Cite this page

510(k) Report. “K914387: Transcervical Intrauterine Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K914387

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