Irrigation Tray with Piston Syringe
FDA 510(k) K942221 · Trinity Laboratories, Inc.
510(k) numberK942221
Submission
- Device name
- Irrigation Tray with Piston Syringe
- Applicant
- Trinity Laboratories, Inc.
Salisbury, MD, US - Received
- May 6, 1994
- Decision date
- August 5, 1994
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K981441 | Heart Cath Tray, Sterile, DisposableDQO · Traditional | 07/10/1998SE |
| K974238 | Dental Tray, Sterile, DisposableEIA · Traditional | 02/04/1998SE |
| K974286 | Circumcision Tray, Cat. No. 70340HFX · Traditional | 12/12/1997SE |
| K972160 | Crp-Lex System: C-Reactive Protein Antigen Detection in Serum: Slide Agglutnation Latex…DCK · Traditional | 08/01/1997SE |
| K970722 | Eye TrayKKX · Traditional | 03/31/1997SE |
| K965201 | O.R. Scrub Prep Tray, Sterile, DisposableLRO · Traditional | 02/14/1997SEKD |
| K964921 | Basic Biopsy Tray. Disposable, SterileLRO · Traditional | 01/22/1997SE |
| K953929 | Mid-Stream Collection Set-SterileLIO · Traditional | 11/16/1995SE |
| K952058 | Sterile V.A.D. (Vascular Access Devices) Access Kit, DisposableFOZ · Traditional | 09/21/1995SE |
| K953070 | Woundfoam 4 X 4KMF · Traditional | 09/08/1995SE |
Questions and answers
When was Irrigation Tray with Piston Syringe cleared by the FDA?
Irrigation Tray with Piston Syringe (K942221) received a 510(k) decision of Unknown on August 5, 1994, 91 days after the submission was received.
What is the product code of K942221?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.