510(k) Report

510(k) · Cleared

Cleared

The Tucker Sling

K932636510(k) TraditionalCleared Jan 26, 1994238-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

Tucker Designs, Ltd. · FRP Holder, Infant Position

Cleared on Jan 26, 1994 after a 238-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Jan 26, 1994
Review
238 days
Class
Class I
Product code
FRP
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2018: 1 descendant cleared1990200020102020
  1. This deviceK932636 The Tucker SlingTucker Designs, Ltd. · 1994
  2. Descendant · cites it directly · 1 of its ownK090284 Res-Q Infant Wedge and SlingCr Enterprises, LLC · 2009
  3. Descendant · 2 generations on · 0 of its ownK172962 Nurture RestNeonatal Loving Kare, Inc. · 2018

Most influential descendants

Showing 2 of 2 · See all
  • K090284Res-Q Infant Wedge and SlingCr Enterprises, LLC · 2009 · cites it directly1descendant
  • K172962Nurture RestNeonatal Loving Kare, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932636The Tucker SlingTucker Designs, Ltd.1994—
+1K090284Res-Q Infant Wedge and SlingCr Enterprises, LLC2009—
+2K172962Nurture RestNeonatal Loving Kare, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201810
FIG. 1 — Lineage of K932636, 1994–2018Source: FDA 510(k) summaries, read by 510(k) Report · 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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  • 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K090284Res-Q Infant Wedge and SlingCr Enterprises, LLC20091

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, K090284 (Cr Enterprises, LLC, 2009) has gone furthest, with 1 descendant of its own.

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—
Cite this page

510(k) Report. “K932636: The Tucker Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932636

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