510(k) Report

510(k) · Cleared

Cleared

Kendall-LTP Turner Save-a-Line

K003511510(k) TraditionalCleared Jan 24, 200171-day reviewClass I21 CFR 880.5680

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

The Ludlow Company LP · FRP Holder, Infant Position

Cleared on Jan 24, 2001 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 24, 2001
Review
71 days
Class
Class I
Product code
FRP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K003511Source: 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 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 FRP devices

FRP Holder, Infant Position: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRP

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRP

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

Recalls per year · FRP

No recall names FRP since 2007.

Adverse event reports per year · FRP

1in 2012

2008: 32009: 12012: 1
2007high 3 (2008) · low 0 (2007)2025

MAUDE reports naming product code FRP, 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—03
20092—01
20100—00
20110—00
20120—01
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 The Ludlow Company LP

3 FDA decisions under this applicant name. See the company

  • K021132Uni-Patch Ultrasound Coupling GelThe Ludlow Company LP · 2002
  • K012218Ludlow Gradient Edge Adult & Pediatric Multifunctional ElectrodesThe Ludlow Company LP · 20014 Class I recalls

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https://510kreport.com/device/K003511 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003511: Kendall-LTP Turner Save-a-Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003511

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