Cleared Traditional

K842215 - ASCORBIC ACID

K842215 is an FDA 510(k) clearance for ASCORBIC ACID, manufactured by Organon Teknika Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K842215 · Organon Teknika Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
59d
Days
Class 2
Risk

K842215 is an FDA 510(k) clearance for the ASCORBIC ACID. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Walker, US). The FDA issued a Cleared decision on August 2, 1984 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K842215

510(k) Number K842215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1984
Decision Date August 02, 1984
Days to Decision 59 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
71d faster than avg
Panel avg: 130d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIP Device Classification - Class 2, Special Controls

Product Code FIP Subsystem, Water Purification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
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 - FIP Subsystem, Water Purification

All 27
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K842215.
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
K944767 · Fresenius USA, Inc. · Nov 1995
SERIM HISENSE TEST KIT
K952215 · Serim Research Corp. · Aug 1995
RENAGUARD DIALYSATE FILTER
K945136 · Minntech Corp. · Feb 1995
HEMO-RO WATER PURIFICATION SYS
K841403 · Millipore Corp. · Jul 1984
EXTRAPURE REVERSE OSMOSIS WATER UNIT
K822385 · Extracorporeal Medical Specialities, Inc. · Oct 1982
GAMBRO WATER PURIFICATION MONITOR WRD
K811678 · Gambro, Inc. · Jul 1981