FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Instylla Delivery Kit
K Number: K253769
·
Decision Dec 22, 2025
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
10
Review Days
27
Basic Information
- Device Name
- Instylla Delivery Kit
- K Number
- K253769
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instylla, Inc.
- Date Received
- November 25, 2025
- Decision Date
- December 22, 2025
- Product Code
- FMF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMF), ordered by most recent decision date.
Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
FDA 510(k)
FDA Class 2
·General Hospital
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
FDA 510(k)
FDA Class 2
·General Hospital
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
FDA 510(k)
FDA Class 2
·General Hospital
Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
FDA 510(k)
FDA Class 2
·General Hospital
DuoprossTM Smart Cap (Type I)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Instylla, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261610 | Verge Microcatheter | Jun 11, 2026 | Substantially Equivalent |
| K253677 | Tembo Embolic System | Dec 15, 2025 | Substantially Equivalent |
| K240873 | TEMBO Embolic System | Dec 16, 2024 | Substantially Equivalent |
| K213632 | Instylla Delivery Kit | Feb 10, 2022 | Substantially Equivalent |
| K210808 | Instylla Microcatheter 1.2 | Apr 15, 2021 | Substantially Equivalent |
| K202544 | Instylla Delivery Kit | Jan 7, 2021 | Substantially Equivalent |
| K200744 | Instylla Microcatheter | Apr 21, 2020 | Substantially Equivalent |
| K191659 | Instylla Delivery Kit | Oct 10, 2019 | Substantially Equivalent |
| K191731 | Instylla Microcatheter | Aug 13, 2019 | Substantially Equivalent |