510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K150562Substantially Equivalent

Safe'n'Sound Staked Passive Delivery System - Plajex version

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

K150562 is the FDA 510(k) clearance record for Safe'n'Sound Staked Passive Delivery System - Plajex version, a class II device, cleared for Nemera on under FDA product code MEG (Syringe, Antistick). FDA records list one 510(k) clearance for Nemera. As of , FDA records show no recalls naming K150562.

Clearance record

Decision date
Received
(88 days to decision)
Product code
MEG Syringe, Antistick
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Nemera 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