Atlas FDA

stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch

FDA 510(k) clearance K173593 · decided 2018-05-21

Clearance details

K-number
K173593
Device name
stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
Decision
Substantially Equivalent
Date received
2017-11-21
Decision date
2018-05-21
Days to decision
181 days
Clearance type
Traditional
Product code
KDJ
Device class
2
Regulation number
876.5630
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Waltham, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch (K250404)Fresenius Medical Care Renal Therapies Group, LLC2025-04-03
MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 (K231849)Baxter Healthcare2024-03-12
15L Cycler Drainage Bag (K214016)Baxter Healthcare Corporation2022-03-18
MiniCap Extended Life PD Transfer Sets (K192705)Baxter Healthcare2019-10-25
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set (K173651)Fresenius Medical Care Renal Therapies Group, LLC2018-02-14
Cycler Drain Bag Set (K173363)Fresenius Medical Care Renal Therapies Group, LLC2018-01-24
Firefly Peritoneal Dialysis Connector Disinfection System (K151620)Puracath Medical, Inc.2016-01-20
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution (K152129)Baxter Healthcare Corporation2015-10-29
EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER (K152675)Baxter Healthcare2015-10-29
APD LUER-LOCK ADAPTER (K124024)Fresensius Medical Care North America2013-09-19
FRESENIUS STERILE STAY SAFE CAP (K083542)Fresenius Medical Care North America2008-12-29
K.E.P. CONNECTOR AND CLIP (K042900)K.E.P., LLC2004-11-05

Recalls involving this device

RecordFirmDate
stay-safe /Safe Lock Catheter Ext. 12 in recall (Z-1323-2024)Fresenius Medical Care Holdings, Inc.2024-03-26
stay-safe /Luer Lock Adapter 4 in recall (Z-1324-2024)Fresenius Medical Care Holdings, Inc.2024-03-26
stay-safe /Luer Lock Catheter Ext. 12 in recall (Z-1325-2024)Fresenius Medical Care Holdings, Inc.2024-03-26
stay-safe /Luer Lock Catheter Ext. 18 in recall (Z-1326-2024)Fresenius Medical Care Holdings, Inc.2024-03-26
stay-safe /Luer Catheter Ext. 6 in recall (Z-1327-2024)Fresenius Medical Care Holdings, Inc.2024-03-26