Cleared Traditional

K991861 - 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE

K991861 is an FDA 510(k) clearance for 1ST RESPONSE INFANT MANUAL RESUSCITATOR, manufactured by Sims Portex, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K991861 · Sims Portex, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
231d
Days
Class 2
Risk

K991861 is an FDA 510(k) clearance for the 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC.... Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Sims Portex, Inc. (Keene, US). The FDA issued a Cleared decision on January 18, 2000 after a review of 231 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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.

FDA 510(k) Submission Details - K991861

510(k) Number K991861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1999
Decision Date January 18, 2000
Days to Decision 231 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 140d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 172
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K991861.
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
K002846 · Headstar Medical Products Co., Ltd. · Jun 2001
AMBU NEONATE SILICONE RESUSCITATOR
K993278 · Ambu, Inc. · May 2000
RUSCH MANUAL RESUSCITATOR BAG
K993194 · Rusch, Inc. · Mar 2000
IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
K992057 · Sims Portex, Inc. · Sep 1999
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
K991955 · Engineered Medical Systems · Jul 1999
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
K991953 · Engineered Medical Systems · Jul 1999
K991861 · 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
Download PDF FDA Summary Sims Portex, Inc.