Cleared Traditional

K903054 - HME-10 (TM)

K903054 is the FDA 510(k) clearance for HME-10 (TM) by Pharma Systems, Inc.. It is a Class 1 Anesthesiology device (product code BYD) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K903054 · Pharma Systems, Inc. · Anesthesiology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Oct 1990

Decision

112d

Days

Class 1

Risk

K903054 is an FDA 510(k) clearance for the HME-10 (TM). Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Pharma Systems, Inc. (Bernardsville, US). The FDA issued a Cleared decision on October 31, 1990 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5375 - 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 Pharma Systems, Inc. devices

Submission Details

510(k) Number	K903054 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 11, 1990
Decision Date	October 31, 1990
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

28d faster than avg

Panel avg: 140d · This submission: 112d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	BYD Condenser, Heat And Moisture (artificial Nose)
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 868.5375

What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BYD Condenser, Heat And Moisture (artificial Nose)

Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K903054.

FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT

K950447 · Vital Signs, Inc. · Feb 1995

5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID

K923865 · Vital Signs, Inc. · Feb 1993

BREATHE EASY

K914336 · Vital Signs, Inc. · Mar 1992

ENGSTROM EDITH MODELS 500,1000,1500 & 1500F

K864095 · Gambro, Inc. · Feb 1987

INLINE FOAM NOSE

K840398 · Mallinckrodt Critical Care · Mar 1984

FOAM NOSE

K840399 · Mallinckrodt Critical Care · Mar 1984

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K903054

Pharma Systems, Inc.

Bernardsville, NJ · US

HAL NORRIS

Regulatory profile

5 submissions 5 cleared

100% clearance rate · Active in Anesthesiology

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,450

Regulatory data since 1976

FDA monthly sync Active