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FDA 510(k)

eRapid with eTrack System

K-Number: K251572 · 2025-12-19

Decision Date2025-12-19
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

eRapid with eTrack System is the device name listed in this FDA 510(k) record. The listed applicant is Pari Respiratory Equipment, Inc.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K251572. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eRapid with eTrack System?

eRapid with eTrack System is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Pari Respiratory Equipment, Inc.. The 510(k) number is K251572.

When did eRapid with eTrack System receive FDA 510(k) clearance?

eRapid with eTrack System received FDA 510(k) clearance on 2025-12-19, under 510(k) number K251572.

Who is the listed applicant for eRapid with eTrack System?

The FDA 510(k) record lists Pari Respiratory Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eRapid with eTrack System?

The FDA product code for eRapid with eTrack System is CAF.

Other records listing Pari Respiratory Equipment, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: CAF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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