Kendall Model 6325 SCD Sequel Compression System
FDA 510(k) K942664 · The Kendal Co.
510(k) numberK942664
Submission
- Device name
- Kendall Model 6325 SCD Sequel Compression System
- Applicant
- The Kendal Co.
Mansfield, MA, US - Received
- June 6, 1994
- Decision date
- January 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JOW – Sleeve, Limb, Compressible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5800
- Specialty
- Cardiovascular
Other 510(k)s with product code JOW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL)JOW · Traditional | Bio Compression Systems, Inc. | 09/11/2026SE |
| K254217 | AerloomJOW · Traditional | Evolym, LLC | 08/31/2026SE |
| K253555 | Flexitouch® Plus Advanced Pneumatic Compression SystemJOW · Traditional | Tactile Medical | 07/31/2026SE |
| K253386 | DVT GarmentJOW · Traditional | Vistar Medical Supplies Co., Ltd. | 06/25/2026SE |
| K250242 | Compression Therapy Device (LGT-2202DVT)JOW · Traditional | Guangzhou Longest Medical Technology Co., Ltd. | 04/24/2026SE |
| K254267 | NanoPress 760A-BT (760A-BT)JOW · Traditional | Mego Afek , Ltd. | 02/24/2026SE |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX)JOW · Traditional | Bio Compression Systems, Inc. | 12/12/2025SE |
| K250190 | Sequential Compression System (SCD600)JOW · Traditional | Shenzhen Comen Medical Instruments Co.,Ltd | 12/08/2025SE |
| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special | Wellell, Inc. | 10/28/2025SE |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001)JOW · Special | Manamed, LLC | 09/17/2025SE |
More from Manamed, LLC
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| K990500 | Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter…EZL · Abbreviated | 09/28/1999SE |
| K991758 | Monoject Insulin SyringeFMF · Abbreviated | 06/14/1999SE |
| K970969 | Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetKOB · Traditional | 04/23/1997SE |
| K951488 | Kendall Curity Catheter Plug with Protective CapKNY · Traditional | 04/25/1995SE |
| K942774 | Polyskin(R) M.R. Moist Responsive Transparent DressingMGP · Traditional | 07/20/1994SN |
| K892434 | Kendall Curity Oxygen MaskBYG · Traditional | 08/15/1989SE |
| K892440 | Kendall Curity Extension TubesFPA · Traditional | 07/24/1989SE |
| K892438 | Kendall Curity Intravascular Cut Down TubesFPA · Traditional | 07/24/1989SE |
| K892436 | Kendall Curity Irrigation SyringeKOD · Traditional | 07/14/1989SE |
Questions and answers
When was Kendall Model 6325 SCD Sequel Compression System cleared by the FDA?
Kendall Model 6325 SCD Sequel Compression System (K942664) received a 510(k) decision of Substantially Equivalent on January 17, 1995, 225 days after the submission was received.
What is the product code of K942664?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.