Medline Safety Insulin and TB Syringes
FDA 510(k) K231907 · Medline Industries, LP
510(k) numberK231907
Submission
- Device name
- Medline Safety Insulin and TB Syringes
- Applicant
- Medline Industries, LP
Northfiled, IL, US - Received
- June 29, 2023
- Decision date
- October 18, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEG – Syringe, Antistick
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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| K252098 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)MEG · Traditional | Methyl Co., Ltd. | 02/18/2026SE |
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| K230287 | SaviSafe Safety DeviceMEG · Traditional | Suzhou Savicred Biotechnology Co., Ltd. | 11/21/2023SE |
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| K220114 | PowerPAK SyringeMEG · Traditional | Vault Paragon Group, Inc. | 01/25/2023SE |
| K221981 | SafeR Syringe and SafeR StingMEG · Traditional | Roncadelle Operations Srl | 12/29/2022SE |
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle)MEG · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 11/23/2022SE |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…MEG · Traditional | Jiangsu Kangbao Medical Equipment Co., Ltd. | 11/01/2022SE |
| K220057 | Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for…MEG · Traditional | Shinva Ande Healthcare Apparatus Co., Ltd. | 10/07/2022SE |
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| K242844 | Medline Level 4 Surgical Gown with Breathable SleevesFYA · Traditional | 02/26/2025SE |
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Questions and answers
When was Medline Safety Insulin and TB Syringes cleared by the FDA?
Medline Safety Insulin and TB Syringes (K231907) received a 510(k) decision of Substantially Equivalent on October 18, 2023, 111 days after the submission was received.
What is the product code of K231907?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.