510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K101233Substantially Equivalent

Safe'n'sound Passive Delivery System

Rexam Pharma, Buffalo Grove IL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101233 is the FDA 510(k) clearance record for SAFE'N'SOUND PASSIVE DELIVERY SYSTEM, a class II device, cleared for Rexam Pharma on under FDA product code MEG (Syringe, Antistick). FDA records list one 510(k) clearance for Rexam Pharma. As of , FDA records show no recalls naming K101233.

Clearance record

Decision date
Received
(291 days to decision)
Product code
MEG Syringe, Antistick
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Rexam Pharma 600 Deerfield Pkwy., Buffalo Grove IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MEG

Trailing 12 months
2 clearances under product code MEG in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MEG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260