Cleared Traditional

K014074 - HOFFRICHTER VECTOR

Also marketed or referenced as:
CPAP WITH HUMIDIFIER OPTION

K014074 is an FDA 510(k) clearance for HOFFRICHTER VECTOR, manufactured by Hoffrichter GmbH. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 590-day FDA review.

K014074 · Hoffrichter GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
590d
Days
Class 2
Risk

K014074 is an FDA 510(k) clearance for the HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALA.... Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Hoffrichter GmbH (Egale, US). The FDA issued a Cleared decision on July 23, 2003 after a review of 590 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Hoffrichter GmbH devices

FDA 510(k) Submission Details - K014074

510(k) Number K014074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2001
Decision Date July 23, 2003
Days to Decision 590 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
450d slower than avg
Panel avg: 140d · This submission: 590d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 307
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K014074.
LYRA NASAL MASK
K031883 · Sensor Medics Corp. · Aug 2003
MIRAGE VISTA MASK
K031047 · Resmed, Ltd. · Aug 2003
VPAP III
K030843 · Resmed, Ltd. · Aug 2003
S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK
K024191 · Resmed, Ltd. · Jul 2003
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
K031460 · Respironics, Inc. · Jun 2003
FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
K023559 · Fisher &Paykel Healthcare , Ltd. · Jun 2003