Cleared Traditional

K912347 - BIPURE 1000

K912347 is an FDA 510(k) clearance for BIPURE 1000, manufactured by Laser Engineering, Inc.. The device is a Class 2 General Hospital device with product code FYD cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K912347 · Laser Engineering, Inc. · General Hospital
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Sep 1991
Decision
118d
Days
Class 2
Risk

K912347 is an FDA 510(k) clearance for the BIPURE 1000. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Laser Engineering, Inc. (Milford, US). The FDA issued a Cleared decision on September 23, 1991 after a review of 118 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5070 - 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.

View all Laser Engineering, Inc. devices

FDA 510(k) Submission Details - K912347

510(k) Number K912347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1991
Decision Date September 23, 1991
Days to Decision 118 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 129d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYD Device Classification - Class 2, Special Controls

Product Code FYD Apparatus, Exhaust, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5070
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 - FYD Apparatus, Exhaust, Surgical

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