Cleared Traditional

K771227 - AK-10

K771227 is an FDA 510(k) clearance for AK-10, manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIL cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K771227 · Gambro, Inc. · Gastroenterology & Urology device
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Aug 1977
Decision
26d
Days
Class 2
Risk

K771227 is an FDA 510(k) clearance for the AK-10. Classified as System, Dialysate Delivery, Single Pass (product code FIL), Class II - Special Controls.

Submitted by Gambro, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1977 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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 Gambro, Inc. devices

FDA 510(k) Submission Details - K771227

510(k) Number K771227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1977
Decision Date August 02, 1977
Days to Decision 26 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 130d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIL Device Classification - Class 2, Special Controls

Product Code FIL System, Dialysate Delivery, Single Pass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FIL System, Dialysate Delivery, Single Pass

Devices cleared under the same product code (FIL) and FDA review panel - the closest regulatory comparables to K771227.
FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM
K890329 · Fresenius USA, Inc. · May 1989
ULTRAFILTRATION SCALE
K781633 · Extracorporeal Medical Specialities, Inc. · Dec 1978
ULTRAFILTRATION MONITOR 5M9034
K771875 · Travenol Laboratories, S.A. · Nov 1977
NEGATIVE PRESSURE ADAPTER 5M1350
K770137 · Travenol Laboratories, S.A. · Feb 1977