510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042556Substantially Equivalent

Shineball PVC Manual Resusciator, ENT-1001, ENT-1003, ENT-1005, Shineball Silicone Manual Resusciator, ENT-1022,

Enter Medical Corporation, Gui Shan Xiang,Tao Yuan Hsien, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042556 is the FDA 510(k) clearance record for SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,, a class II device, cleared for Enter Medical Corporation on under FDA product code BTM (Ventilator, Emergency, Manual (Resuscitator)). FDA records list one 510(k) clearance for Enter Medical Corporation. As of , FDA records show no recalls naming K042556.

Clearance record

Decision date
Received
(172 days to decision)
Product code
BTM Ventilator, Emergency, Manual (Resuscitator)
Regulation
21 CFR 868.5915
Device class
Class II
Review panel
Anesthesiology
Applicant
Enter Medical Corporation #16-1, Ln. 564, Gui Shan Xiang,Tao Yuan Hsien, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BTM

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