510(k) Report

510(k) · Cleared

Cleared

Tri-Med Quick-Step (TM) Rectal Tube

K924549510(k) TraditionalCleared Feb 10, 1994519-day reviewClass II21 CFR 876.5980

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

Tri-Med Specialties, Inc. · GBT Catheter, Rectal

Cleared on Feb 10, 1994 after a 519-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Feb 10, 1994
Review
519 days
Class
Class II
Product code
GBT
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 K924549Source: 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.

Planning a device in GBT? 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?

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 GBT devices

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

FDA decisions per year · GBT

FDA has decided no GBT device since 2007.

Median 510(k) review, days · GBT

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

Recalls per year · GBT

No recall names GBT since 2007.

Adverse event reports per year · GBT

1in 2010

2007: 12009: 12010: 1
2007high 1 (2007) · low 0 (2008)2025

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

More from Tri-Med Specialties, Inc.

14 FDA decisions under this applicant name. See the company

  • K971615Pattison Esophageal DilatorTri-Med Specialties, Inc. · 1997
  • K970890#ES-32 Suction Catheter 32 FR.Tri-Med Specialties, Inc. · 1997
  • K970982T-RX Retrieval ForcepsTri-Med Specialties, Inc. · 1997
  • K942918Tri-Med Endoscopic Fluid Introduction CatheterTri-Med Specialties, Inc. · 1995
  • K950574Needle/CannulaTri-Med Specialties, Inc. · 1995

Recent decisions in GBT

The GBT category page

  • K941391Inflatable Retention Cuff SpeculumInnovatec Medical Corp. · 1994
  • K890466Sigmoid TonomitorTonometrics, Inc. · 1989

https://510kreport.com/device/K924549 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924549: Tri-Med Quick-Step (TM) Rectal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924549

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