Cleared Traditional

K033448 - ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER

K033448 is an FDA 510(k) clearance for ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER, manufactured by John Mfg., Ltd.. The device is a Class 2 General Hospital device with product code FRA cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K033448 · John Mfg., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
257d
Days
Class 2
Risk

K033448 is an FDA 510(k) clearance for the ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER. Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by John Mfg., Ltd. (Walnut, US). The FDA issued a Cleared decision on July 12, 2004 after a review of 257 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6500 - 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.

FDA 510(k) Submission Details - K033448

510(k) Number K033448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2003
Decision Date July 12, 2004
Days to Decision 257 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 129d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRA Device Classification - Class 2, Special Controls

Product Code FRA Purifier, Air, Ultraviolet, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6500
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 - FRA Purifier, Air, Ultraviolet, Medical

All 35
Devices cleared under the same product code (FRA) and FDA review panel - the closest regulatory comparables to K033448.
ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI
K133800 · Hgi Industires · Dec 2014
ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400
K062716 · Eco-Rx, Inc. · Oct 2006
ABRACAIR AIR CLEANER, MODEL QTZ300-60
K052732 · Abracair, Inc. · Feb 2006
AIROCIDE TI02
K023830 · Kes Science & Technology, Inc. · Feb 2003
SECOND WIND AIR PURIFIER
K980745 · Monagan Ent., Inc. · Apr 1999
MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV
K972064 · Biological Controls, Inc. · Dec 1997
K033448 · ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER
Download PDF FDA Summary John Mfg., Ltd.