Chrysalis Intelligence · Product Codes · QOI

QOI · Intravenous Catheter Force-Activated Separation Device.

General Hospital · 8 clearances · 3 unique sponsors

Device class
Class II
Regulation 880.5220
Total clearances
8
2021-05-27 → 2024-09-06
Last 12 months
0
Unique sponsors
3
Definition

What is Intravenous Catheter Force-Activated Separation Device.

An intravenous (IV) catheter force-activated separation device. An intravenous catheter force-activated separation device is placed inline with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.
Medical specialty
General Hospital
Review panel
HO
Regulation number
880.5220
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Linear Health Sciences, LLC 4 0 2024-09-06
Lineus Medical, LLC 3 0 2023-09-29
Site Saver, Inc. D/B/A Lineus Medical 1 0 2021-05-27
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
36568 CPT Medium Insertion of peripherally inserted central venous catheter (PICC); applicable for IV catheter-related procedures with separation device
36569 CPT Medium Insertion of peripherally inserted central venous catheter (PICC) with imaging; alternative for catheter placement procedures
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2024-09-06 K241415 Linear Health Sciences, LLC Orchid Safety Release Valve™
2023-10-03 K232094 Linear Health Sciences, LLC Orchid Safety Release ValveTM
2023-09-29 K231957 Lineus Medical SafeBreak® Vascular
2023-05-19 K223486 Lineus Medical SafeBreak® Vascular
2023-05-04 K230266 Linear Health Sciences, LLC Orchid Safety Release Valve
2022-10-16 K222791 Lineus Medical, LLC SafeBreak Vascular
2022-05-03 K212064 Linear Health Sciences, LLC Orchid Safety Release Valve(TM)
2021-05-27 DEN190043 Site Saver, Inc. D/B/A Lineus Medical SafeBreak Vascular