PuraCath Firefly Needleless Connector IT (9005)— 510(k) K251375
Substantially EquivalentPuracath Medical, Inc.
FDA 510(k) clearance K251375 for PuraCath Firefly Needleless Connector IT (9005), Substantially Equivalent on 2026-02-12. Applicant: Puracath Medical, Inc.. Device class: 2.
Summary
Puracath Medical's PuraCath Firefly Needleless Connector IT (9005) is filed under product code FPA, intravascular administration set. The record doesn't describe the connector beyond its name and that code name.
Class II, 21 CFR 880.5440. General Hospital is both the classification panel and the review panel. It came in as a Traditional 510(k).
Puracath Medical filed from Newark, California. FDA found it substantially equivalent 286 calendar days after receipt (May 2, 2025 to February 12, 2026).
Clearance details
- Applicant
- Puracath Medical, Inc.
- Product code
- Product code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, CA, US
Recent devices under product code FPA
view all- K260261 — Gravity Blood Sets with 200µm Filter
- K254123 — Ecomed Disposable Administration Sets
- K261530 — iiSure Infusion Set
- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Puracath Medical, Inc.
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.