Pedia-Thor Thoracostomy Kit
FDA 510(k) K913540 · Intl. Medical Devices , Ltd.
510(k) numberK913540
Submission
- Device name
- Pedia-Thor Thoracostomy Kit
- Applicant
- Intl. Medical Devices , Ltd.
Los Angeles, CA, US - Received
- August 9, 1991
- Decision date
- April 9, 1992
- Decision
- Substantially Equivalent (SESE)
- 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
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| 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 |
|---|---|---|
| K913541 | Neo-Thor Thoracostomy KitFMF · Traditional | 04/09/1992SE |
| K913542 | Thoracic Catheter with GuideGBX · Traditional | 01/21/1992SE |
| K913539 | Thoracic Cathter StyletGBX · Traditional | 01/21/1992SE |
| K913543 | Thoracic Catheter StyletDRB · Traditional | 10/04/1991SE |
| K862909 | Re-Trake Weiss Emergency Airway & Thoracic SystemBTO · Traditional | 09/09/1986SE |
| K850398 | Nu-Cath Emergency KitFOZ · Traditional | 03/27/1985SE |
| K843785 | Wisss Pediatric Trach- Tube W/ObturatorBTO · Traditional | 10/23/1984SE |
| K842666 | Nu-Thor Thoracostomy KitKGZ · Traditional | 09/20/1984SE |
| K840925 | Pedia-Trake Cricothyrotomy KitBTO · Traditional | 05/02/1984SE |
| K820778 | Respiration Monitor 1000BZQ · Traditional | 05/03/1982SE |
Questions and answers
When was Pedia-Thor Thoracostomy Kit cleared by the FDA?
Pedia-Thor Thoracostomy Kit (K913540) received a 510(k) decision of Substantially Equivalent on April 9, 1992, 244 days after the submission was received.
What is the product code of K913540?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.