Cleared Traditional

K203796 - Firefly Needleless Connector

K203796 is an FDA 510(k) clearance for Firefly Needleless Connector, manufactured by Puracath Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K203796 · Puracath Medical, Inc. · General Hospital
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Jul 2021
Decision
214d
Days
Class 2
Risk

K203796 is an FDA 510(k) clearance for the Firefly Needleless Connector. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Puracath Medical, Inc. (Newark, US). The FDA issued a Cleared decision on July 30, 2021 after a review of 214 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Puracath Medical, Inc. devices

FDA 510(k) Submission Details - K203796

510(k) Number K203796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2020
Decision Date July 30, 2021
Days to Decision 214 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 129d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K203796.
IV Administration Sets
K202618 · B.Braun Medical, Inc. · Sep 2021
I.V. Administration Set
K210381 · Bq Plus Medical Co., Ltd. · Aug 2021
Insignis Subcutaneous Needle Sets
K202279 · Innovative Health Sciences, LLC · Aug 2021
Medtronic Extended infusion set
K210544 · Unomedical A/S · Jul 2021
Intravascular Extension Set
K210430 · Baxter Healthcare Corporation · Jun 2021
Needleless Connector
K210217 · Jiangsu Caina Medical Co.,Ltd · May 2021