510(k) Report

510(k) · Cleared

Cleared

Baby Pod

K030283510(k) TraditionalCleared Apr 22, 200385-day reviewClass I21 CFR 880.6900

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

Prism Enterprises, Inc. · FPP Stretcher, Hand-Carried

Cleared on Apr 22, 2003 as substantially equivalent to K902521 (W. Murphy Ent., Inc., 1990) after an 85-day review. Its family tree reaches back 1 generation to 1990.

Decided
Apr 22, 2003
Review
85 days
Class
Class I
Product code
FPP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K902521 (1990). No later device cites it as a predicate yet.

K902521 · Weevac 6 Infant Evacuation Stretcher · W. Murphy Ent., Inc. · 19901990199520002005
K902521 · Weevac 6 Infant Evacuation Stretcher · W. Murphy Ent., Inc. · 19900
  1. Root · 1 generation backK902521 Weevac 6 Infant Evacuation StretcherW. Murphy Ent., Inc. · 1990
  2. This deviceK030283 Baby PodPrism Enterprises, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K902521Weevac 6 Infant Evacuation StretcherW. Murphy Ent., Inc.1990—
0 (this device)K030283Baby PodPrism Enterprises, Inc.2003—
FIG. 1 — Lineage of K030283, 1990–2003Source: 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), 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 FPP? 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K902521Weevac 6 Infant Evacuation Stretcher
Summary page 1
…pediatric carrier- stretcher accessory SUBSTANTIALLY EQUIVALENT TO: The Baby Pod is substantially equivalent to WEEVAC 6 lnfant Evacuation Stretcher (K90252 1). The Ti-ansWarmer@lwarmer mattress, an accessory used with the Baby Pod, was previously cleared for market (K93463 1.) The Baby…
W. Murphy Ent., Inc.1990—

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.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All FPP devices

FPP Stretcher, Hand-Carried: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPP

FDA has decided no FPP device since 2007.

Median 510(k) review, days · FPP

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

Recalls per year · FPP

3in 2016

2008: 42009: 22011: 32016: 3
2007high 4 (2008) · low 0 (2007)2026

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

Adverse event reports per year · FPP

53in 2025

2007: 12008: 22009: 72010: 162011: 842012: 832013: 2022014: 1182015: 1192016: 112017: 902018: 1542019: 332020: 312021: 542022: 362023: 412024: 272025: 53
2007high 202 (2013) · low 1 (2007)2025

MAUDE reports naming product code FPP, 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—42
20090—27
20100—016
20110—384
20120—083
20130—0202
20140—0118
20150—0119
20160—311
20170—090
20180—0154
20190—033
20200—031
20210—054
20220—036
20230—041
20240—027
20250—053
20260—0—

What is it indicated for?

Baby Pod is intended to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility.

Indications for use as stated in the FDA summary.

More from Prism Enterprises, Inc.

4 FDA decisions under this applicant name. See the company

  • K020447Mityvac Merlin, Model 10027Prism Enterprises, Inc. · 2002
  • K011532MityvacPrism Enterprises, Inc. · 20014 recalls
  • K000444Mityview 4-Way Lateral Expander SpeculumPrism Enterprises, Inc. · 2000

Recent decisions in FPP

The FPP category page

  • K942356Med-Evac-4 Medical Evacuation StretcherMontery Bay Corp. · 1994
  • K940130Stryker Model 6110 Emergency/Pole StretcherStryker Corp. · 1994
  • K940245Evacu-SledEvacu Technologies, Inc. · 1994
  • K924275Restraining StretcherDms · 1993
  • K922816U P Custom Design, Inc. Cot Equipment CarrierUp Custom Design, Inc. · 1993

https://510kreport.com/device/K030283 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030283: Baby Pod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030283

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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