Cleared Traditional

K211680 - Streamline Surgical System

K211680 is an FDA 510(k) clearance for Streamline Surgical System, manufactured by New World Medical, Inc.. The device is a Class 2 Ophthalmic device with product code MRH cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K211680 · New World Medical, Inc. · Ophthalmic device
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Oct 2021
Decision
129d
Days
Class 2
Risk

K211680 is an FDA 510(k) clearance for the Streamline Surgical System. Classified as Pump, Infusion, Ophthalmic (product code MRH), Class II - Special Controls.

Submitted by New World Medical, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on October 8, 2021 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 880.5725 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all New World Medical, Inc. devices

FDA 510(k) Submission Details - K211680

510(k) Number K211680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2021
Decision Date October 08, 2021
Days to Decision 129 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 110d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRH Device Classification - Class 2, Special Controls

Product Code MRH Pump, Infusion, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - MRH Pump, Infusion, Ophthalmic

All 8
Devices cleared under the same product code (MRH) and FDA review panel - the closest regulatory comparables to K211680.
OMNI Surgical System
K232214 · Sight Sciences, Inc. · Aug 2023
TrabEx Pro
K213173 · Microsurgical Technologies, Inc. · Jun 2022
iPrime Viscodelivery System
K212797 · Glaukos · Jan 2022
OMNI Surgical System
K202678 · Sight Sciences, Inc. · Mar 2021
OMNI PLUS Surgical System
K201953 · Sight Sciences, Inc. · Aug 2020
VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
K993039 · Bausch & Lomb, Inc. · Jan 2000