510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030283Substantially Equivalent

Baby Pod

Prism Enterprises, Inc., Stillwater MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030283 is the FDA 510(k) clearance record for BABY POD, a class I device, cleared for Prism Enterprises, Inc. on under FDA product code FPP (Stretcher, Hand-Carried). FDA records list 4 510(k) clearances for Prism Enterprises, Inc., from to . As of , FDA records show no recalls naming K030283.

Clearance record

Decision date
Received
(85 days to decision)
Product code
FPP Stretcher, Hand-Carried
Regulation
21 CFR 880.6900
Device class
Class I
Review panel
General Hospital
Applicant
Prism Enterprises, Inc. P.O. Box 560, Stillwater MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FPP

Trailing 12 months

FDA records hold no clearances under product code FPP in the trailing twelve months.

FDA records show no clearances under product code FPP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FPP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260