510(k) Report

510(k) · Cleared

Cleared

Nature's Cradle

K951024510(k) TraditionalCleared Jun 5, 199591-day reviewClass II21 CFR 880.5140

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

Infant Advantage, Inc. · FMS Bed, Pediatric Open Hospital

Cleared on Jun 5, 1995 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 5, 1995
Review
91 days
Class
Class II
Product code
FMS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K951024Source: 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 FMS? 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 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 FMS devices

FMS Bed, Pediatric Open Hospital: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMS

FDA has decided no FMS device since 2007.

Median 510(k) review, days · FMS

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

Recalls per year · FMS

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FMS

25in 2025

2007: 72008: 22009: 72010: 202011: 672012: 802013: 1362014: 1572015: 1752016: 1372017: 1212018: 1132019: 302020: 282021: 282022: 222023: 292024: 302025: 25
2007high 175 (2015) · low 2 (2008)2025

MAUDE reports naming product code FMS, 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—07
20080—02
20090—07
20100—020
20110—067
20120—080
20130—0136
20140—0157
20150—0175
20160—0137
20170—0121
20180—0113
20190—130
20200—028
20210—028
20220—022
20230—029
20240—030
20250—025
20260—0—

More from Infant Advantage, Inc.

5 FDA decisions under this applicant name. See the company

  • K970334Nature's CradleInfant Advantage, Inc. · 1997
  • K960747Nature's Cradle Model C1500Infant Advantage, Inc. · 1996
  • K921327Nature's Cradle HM-10Infant Advantage, Inc. · 1992
  • K901763Nature's Cradle (TM)Infant Advantage, Inc. · 1991

Recent decisions in FMS

The FMS category page

  • K970334Nature's CradleInfant Advantage, Inc. · 1997
  • K963210Vail 100 Pediatric CribVail Products, Inc. · 1996
  • K960747Nature's Cradle Model C1500Infant Advantage, Inc. · 1996
  • K960012Stryker Adel BassinetStryker Corp. · 1996
  • K950059MC Infant Care Unie #PP30Janco Consulting Services · 1995

https://510kreport.com/device/K951024 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951024: Nature's Cradle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951024

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