Spike Guard
FDA 510(k) K812130 · Clinipad Corp.
510(k) numberK812130
Submission
- Device name
- Spike Guard
- Applicant
- Clinipad Corp.
Mchenry, IL, US - Received
- July 27, 1981
- Decision date
- September 9, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDJ – Set, Administration, For Peritoneal Dialysis, Disposable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code KDJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250404 | staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter…KDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 04/03/2025SE |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional | Baxter Healthcare | 03/12/2024SE |
| K214016 | 15L Cycler Drainage BagKDJ · Traditional | Baxter Healthcare Corporation | 03/18/2022SE |
| K192705 | MiniCap Extended Life PD Transfer SetsKDJ · Special | Baxter Healthcare | 10/25/2019SE |
| K173593 | staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension…KDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/21/2018SE |
| K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetKDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/14/2018SE |
| K173363 | Cycler Drain Bag SetKDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 01/24/2018SE |
| K151620 | Firefly Peritoneal Dialysis Connector Disinfection SystemKDJ · Traditional | Puracath Medical, Inc. | 01/20/2016SE |
| K152675 | Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and…KDJ · Traditional | Baxter Healthcare | 10/29/2015SE |
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine…KDJ · Traditional | Baxter Healthcare Corporation | 10/29/2015SE |
More from Baxter Healthcare Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K931560 | Cardiac Catheterization TrayDQO · Traditional | 07/11/1994SEKD |
| K931668 | Picc Insertion TrayFOZ · Traditional | 03/07/1994SEKD |
| K932071 | I.V. Start KitFOZ · Traditional | 02/17/1994SEKD |
| K932010 | V.A.D. Access KitLJT · Traditional | 02/03/1994SE |
| K932036 | Laceration TrayFRG · Traditional | 12/13/1993SESK |
| K932016 | Tracheostomy Care TrayJOH · Traditional | 11/03/1993SE |
| K862562 | Punch Biopsy KitKNW · Traditional | 10/07/1986SE |
| K862563 | Tracheostomy Cleansing SolutionEPE · Traditional | 07/15/1986SE |
| K833075 | Wet Dressing KitKDD · Traditional | 01/27/1984SE |
| K833432 | Catheter Insertion KitKOD · Traditional | 12/28/1983SE |
Questions and answers
When was Spike Guard cleared by the FDA?
Spike Guard (K812130) received a 510(k) decision of Substantially Equivalent on September 9, 1981, 44 days after the submission was received.
What is the product code of K812130?
The FDA product code is KDJ – Set, Administration, For Peritoneal Dialysis, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5630.