Cleared Traditional

K120384 - PROTECTOR, INJECTOR, CONNECTOR

K120384 is an FDA 510(k) clearance for PROTECTOR, manufactured by Bd Medical-Medical Surgical Systems. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K120384 · Bd Medical-Medical Surgical Systems · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
218d
Days
Class 2
Risk

K120384 is an FDA 510(k) clearance for the PROTECTOR, INJECTOR, CONNECTOR. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Bd Medical-Medical Surgical Systems (Franklin Lakes, US). The FDA issued a Cleared decision on September 12, 2012 after a review of 218 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K120384

510(k) Number K120384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2012
Decision Date September 12, 2012
Days to Decision 218 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 129d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - LHI Set, I.v. Fluid Transfer

All 189
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K120384.
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K120150 · B.Braun Medical, Inc. · May 2012
K120384 · PROTECTOR, INJECTOR, CONNECTOR
Download PDF FDA Summary Bd Medical-Medical Su…