Cleared Traditional

K871258 - BIOSURGE MODEL OASYS

K871258 is an FDA 510(k) clearance for BIOSURGE MODEL OASYS, manufactured by Biosurge, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K871258 · Biosurge, Inc. · Anesthesiology device
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May 1987
Decision
51d
Days
Class 2
Risk

K871258 is an FDA 510(k) clearance for the BIOSURGE MODEL OASYS. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Biosurge, Inc. (Rochester, US). The FDA issued a Cleared decision on May 21, 1987 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5830 - the FDA anesthesiology and respiratory 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 Biosurge, Inc. devices

FDA 510(k) Submission Details - K871258

510(k) Number K871258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1987
Decision Date May 21, 1987
Days to Decision 51 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 140d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAC Device Classification - Class 2, Special Controls

Product Code CAC Apparatus, Autotransfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5830
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAC Apparatus, Autotransfusion

All 168
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K871258.
PLEURA-GARD ATS
K871568 · Conmedcorp · Jun 1987
THORA-DRAIN(R) ABT SYSTEM
K871624 · Sherwood Medical Co. · Jun 1987
BT-795/ATS
K871847 · Electromedics, Inc. · Jun 1987
ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM
K864374 · Sherwood Medical Co. · Mar 1987
AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900
K862684 · Boehringer Laboratories · Oct 1986
PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT
K861677 · American Pharmaseal Div. Ahsc · Jun 1986