Cytotran I Bone Marrow Aspiration System
FDA 510(k) K802406 · Applied Medical Devices, Inc.
510(k) numberK802406
Submission
- Device name
- Cytotran I Bone Marrow Aspiration System
- Applicant
- Applied Medical Devices, Inc.
Mchenry, IL, US - Received
- October 3, 1980
- Decision date
- January 15, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
Other 510(k)s with product code FMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | SurGenTec, LLC | 08/26/2026SE |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | Sol-Millennium Medical, Inc. | 08/25/2026SE |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
| K260208 | Ultra-Fine SAFETY Insulin SyringeFMF · Traditional | embecta Medical II, LLC | 07/13/2026SE |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 06/18/2026SE |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional | CMT Health PTE., Ltd. | 06/12/2026SE |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special | Hlb Lifescience Co., Ltd. | 05/21/2026SE |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
More from Instylla, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843885 | Percutaneous Aspiration Biopsy Tray · Traditional | 12/19/1984SE |
| K843884 | General Utility Tray System · Traditional | 12/13/1984SE |
| K843883 | Sterile Percutaneous Transhepatic Cholan · Traditional | 12/13/1984SE |
| K840904 | Accu-Cult Fecal Occult Blood TestKHE · Traditional | 08/16/1984SE |
| K842591 | Ultrasound Probe Covers-SterileIYO · Traditional | 07/23/1984SE |
| K833720 | Transthoracic/Transabdominal-TrayGDM · Traditional | 05/30/1984SE |
| K840334 | Chemonucleolysis/Discography TrayFMI · Traditional | 04/13/1984SE |
| K833438 | Prepacell-Sterile-Bone Marrow AspirKDD · Traditional | 02/09/1984SE |
| K833719 | Prepacell Thin Needle Aspiration TrayKOD · Traditional | 01/25/1984SE |
| K791660 | Prepacell-Bone Marrow SamplerFMF · Traditional | 09/12/1979SE |
Questions and answers
When was Cytotran I Bone Marrow Aspiration System cleared by the FDA?
Cytotran I Bone Marrow Aspiration System (K802406) received a 510(k) decision of Substantially Equivalent on January 15, 1981, 104 days after the submission was received.
What is the product code of K802406?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.