510(k) Report

510(k) · Cleared

Cleared

Wrench, Gexagon, Driver

K781179510(k) TraditionalCleared Jul 27, 197813-day reviewClass I21 CFR 870.3730

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

Telectronics, Inc. · DTF Tools, Pacemaker Service

Cleared on Jul 27, 1978 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 27, 1978
Review
13 days
Class
Class I
Product code
DTF
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K781179Source: 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 DTF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, 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 DTF devices

DTF Tools, Pacemaker Service: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTF

FDA has decided no DTF device since 2007.

Median 510(k) review, days · DTF

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

Recalls per year · DTF

No recall names DTF since 2007.

Adverse event reports per year · DTF

1in 2014

2007: 12009: 12012: 22014: 1
2007high 2 (2012) · low 0 (2008)2025

MAUDE reports naming product code DTF, 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—00
20110—00
20120—02
20130—00
20140—01
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 Telectronics, Inc.

113 FDA decisions under this applicant name. See the company

  • P850027/S006Telectronics Pasar Model 4171 PGTelectronics, Inc. · 1990
  • P850027/S003Telectronics Pasar Model 4171 PGTelectronics, Inc. · 1990
  • K890895Implantable Adaptor 033-380Telectronics, Inc. · 1990
  • P850027/S005Telectronics Pasar Model 4171 PGTelectronics, Inc. · 1990
  • K891231Optima MPT and SPT PacemakersTelectronics, Inc. · 1989

Recent decisions in DTF

The DTF category page

  • K875147Torque Hex WrenchCardiac Pacemakers, Inc. · 1988

https://510kreport.com/device/K781179 · printed Nov 6, 2026

Cite this page

510(k) Report. “K781179: Wrench, Gexagon, Driver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K781179

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