Cleared Traditional

K980829 - 3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP

K980829 is an FDA 510(k) clearance for 3ML STERI-NEB SALINE - 0.9% W/V SODIUM ..., manufactured by Steripak, Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980829 · Steripak, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
90d
Days
Class 2
Risk

K980829 is an FDA 510(k) clearance for the 3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Steripak, Ltd. (Northvale, US). The FDA issued a Cleared decision on June 2, 1998 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Steripak, Ltd. devices

FDA 510(k) Submission Details - K980829

510(k) Number K980829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1998
Decision Date June 02, 1998
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 248
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K980829.
METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D
K981249 · Instrumentation Industries, Inc. · Nov 1998
MYSTIQUE ULTRASONIC NEBULIZER
K983002 · Airsep Corp. · Oct 1998
BREATHERITE
K981944 · Ventlab Corp. · Aug 1998
HOPE NEBULIZER
K980407 · B&B Medical Technologies, Inc. · May 1998
STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR
K973532 · Dhd Diemolding Healthcare Div. · Mar 1998
ULTRANEB
K974379 · Bremed Italia, S.R.L. · Feb 1998