Cleared Traditional

K203378 - Pulsehaler (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203378 · Respinova, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
134d
Days
Class 2
Risk

K203378 is an FDA 510(k) clearance for the Pulsehaler. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Respinova, Ltd. (Herzliya, IL). The FDA issued a Cleared decision on March 31, 2021 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - 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 Respinova, Ltd. devices

Submission Details

510(k) Number K203378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2020
Decision Date March 31, 2021
Days to Decision 134 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
5d faster than avg
Panel avg: 139d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BWF Spirometer, Therapeutic (incentive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5690
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 Consultant

Ironstone Product Development, Inc.
Joel Ironstone

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BWF Spirometer, Therapeutic (incentive)

All 107
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K203378.
InSee
K241152 · Tidal Medical Technologies, LLC · Aug 2025
AllPEP
K233855 · Enchant Tek Co. , Ltd. · Feb 2024
LungTrainer (MD2 & MD3)
K221058 · Lung Trainers, LLC · Jul 2023
Breathe+
K222018 · Peep Medical, LLC Dba Go2 Devices · Jun 2023
Hudson RCI Triflo II Incentive Deep Breathing Exerciser
K220565 · Medline Industries, Inc. · Oct 2022