510(k) Report

510(k) · Cleared

Cleared

Automatic Tubing Clamp

K914459510(k) TraditionalCleared Jun 24, 1992261-day reviewClass II21 CFR 876.5820

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

Rocky Mountain Research, Inc. · FIG Clamp, Tubing, Blood, Automatic

Cleared on Jun 24, 1992 after a 261-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Jun 24, 1992
Review
261 days
Class
Class II
Product code
FIG
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared1990200020102020
  1. This deviceK914459 Automatic Tubing ClampRocky Mountain Research, Inc. · 1992
  2. Descendant · cites it directly · 0 of its ownK093915 Deka Tac DeviceDeka Research & Development Corp. · 2011

Most influential descendants

Showing 1 of 1 · See all
  • K093915Deka Tac DeviceDeka Research & Development Corp. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914459Automatic Tubing ClampRocky Mountain Research, Inc.1992—
+1K093915Deka Tac DeviceDeka Research & Development Corp.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
FIG. 1 — Lineage of K914459, 1992–2011Source: 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.

Planning a device in FIG? 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
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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093915Deka Tac DeviceDeka Research & Development Corp.20110

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?

  • Of its descendants, K093915 (Deka Research & Development Corp., 2011) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FIG devices

FIG Clamp, Tubing, Blood, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FIG

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FIG

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

Recalls per year · FIG

No recall names FIG since 2007.

Adverse event reports per year · FIG

No MAUDE report names FIG since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—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—
Cite this page

510(k) Report. “K914459: Automatic Tubing Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914459

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