510(k) · Cleared

Cleared

Nature's Cradle Model C1500

K960747510(k) TraditionalCleared May 22, 199689-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 May 22, 1996 as substantially equivalent to K901763 (Infant Advantage, Inc., 1991) after an 89-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.

Decided: May 22, 1996
Review: 89 days
Class: Class II
Product code: FMS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K901763 (1991). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK901763 Nature's Cradle (TM)Infant Advantage, Inc. · 1991
This deviceK960747 Nature's Cradle Model C1500Infant Advantage, Inc. · 1996
Descendant · cites it directly · 0 of its ownK970334 Nature's CradleInfant Advantage, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all

K970334Nature's CradleInfant Advantage, Inc. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K901763	Nature's Cradle (TM)	Infant Advantage, Inc.	1991	—
0 (this device)	K960747	Nature's Cradle Model C1500	Infant Advantage, Inc.	1996	—
+1	K970334	Nature's Cradle	Infant Advantage, Inc.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K960747, 1991–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K901763	Nature's Cradle (TM) Summary page 1 …500 is a new device that is based on the same technology and the same indications for use as Nature’s Cradle® Infant Bassinet, Model M-1, 510(k) Premarket Notification # K901763. The moving platform is now embedded in the mattress, thus omitting the bassinett. The new mattress fits standard crib size (27 1…	Infant Advantage, Inc.	1991	—

Also cleared against K901763: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K970334	Nature's Cradle	Infant Advantage, Inc.	1997	0

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?

Its one ancestor has no recall.
Of its descendants, K970334 (Infant Advantage, Inc., 1997) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K901763.

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

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

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

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	7
2008	—	0	2
2009	—	0	7
2010	—	0	20
2011	—	0	67
2012	—	0	80
2013	—	0	136
2014	—	0	157
2015	—	0	175
2016	—	0	137
2017	—	0	121
2018	—	0	113
2019	—	1	30
2020	—	0	28
2021	—	0	28
2022	—	0	22
2023	—	0	29
2024	—	0	30
2025	—	0	25
2026	—	0	—

What is it indicated for?

The Nature’s Cradle® Model C1500, when used as directed, is designed to provide a safe and effective transition to infants after birth, allowing them to grow accustomed to their new environment at a pace that minimizes stress. The mattress is equipped with motion and sound designed to simulate the mother’s heartbeat and circulatory system familiar to the infant during the last trimester of pregnancy. Nature’s Cradle® Model C1500 is intended to be used for healthy, full term infants at home from 0-16 weeks. The Nature’s Cradle® Model C1500 is non-sterile and reusable.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K960747 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960747: Nature's Cradle Model C1500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960747

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026