Cleared Traditional

K882291 - RETROFIT BABY FACE SHIELD (RFS) (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K882291 · Physician Engineered Products, Inc. · General Hospital
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Jun 1988
Decision
19d
Days
Class 2
Risk

K882291 is an FDA 510(k) clearance for the RETROFIT BABY FACE SHIELD (RFS). Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Physician Engineered Products, Inc. (Park Rapids, US). The FDA issued a Cleared decision on June 20, 1988 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5700 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Physician Engineered Products, Inc. devices

Submission Details

510(k) Number K882291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1988
Decision Date June 20, 1988
Days to Decision 19 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 128d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBI Unit, Neonatal Phototherapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5700
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.