510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K211680Substantially Equivalent

Streamline Surgical System

New World Medical, Inc., Rancho Cucamonga CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211680 is the FDA 510(k) clearance record for Streamline Surgical System, a class II device, cleared for New World Medical, Inc. on under FDA product code MRH (Pump, Infusion, Ophthalmic). FDA records list 12 510(k) clearances for New World Medical, Inc., from to . As of , FDA records show no recalls naming K211680.

Clearance record

Decision date
Received
(129 days to decision)
Product code
MRH Pump, Infusion, Ophthalmic
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
New World Medical, Inc. 10763 Edison Ct., Rancho Cucamonga CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRH

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