Cleared Traditional

K100380 - ALTERA NEBULIZER SYSTEM, MODEL 678G1002

K100380 is an FDA 510(k) clearance for ALTERA NEBULIZER SYSTEM, manufactured by Pari Respiratory Equipment, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K100380 · Pari Respiratory Equipment, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
6d
Days
Class 2
Risk

K100380 is an FDA 510(k) clearance for the ALTERA NEBULIZER SYSTEM, MODEL 678G1002. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Pari Respiratory Equipment, Inc. (Midlothian, US). The FDA issued a Cleared decision on February 22, 2010 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 Pari Respiratory Equipment, Inc. devices

FDA 510(k) Submission Details - K100380

510(k) Number K100380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date February 22, 2010
Days to Decision 6 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d faster than avg
Panel avg: 140d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 407
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K100380.
MERITS MODEL N SERIES NEBULIZER COMPRESSORS
K092859 · Merits Health Products Co., Ltd. · Jul 2010
LITETOUCH MASK
K100285 · Respironics New Jersey, Inc. · Jun 2010
PARI SINUS
K092560 · Pari Respiratory Equipment, Inc. · May 2010
PARI VIOS
K092918 · Pari Respiratory Equipment, Inc. · Feb 2010
CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202
K091794 · Steve Islava · Jan 2010
RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
K091111 · Instrumentation Industries, Inc. · Dec 2009