# K081547: Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CC

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Med USA, Inc.
- Decided: Sep 8, 2008 after 98 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K941657 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024112: BD Insulin Syringe, Becton, Dickinson & CO (2003) Summary page 1.
- K980580: Becton Dickinson Syringes, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.
- K991758: Monoject Insulin Syringe, The Kendal Co. (1999) Summary page 1.
- K851090: Monoject Sterile 1/2 CC & 1CC Syringes W & W/O Nee, Sherwood Medical Co. (1985) Summary page 1.
- K992802: Terumo U-100 Insulin Syringe, Terumo Medical Corp. (1999) Summary page 1.
- K070917: Feel-Ject Insulin Syringe, Feel Tech (2007) Summary page 1.
- K063348: Top Fine Insulin Syringe, Daejin Tech Medical Manufacturing Co., Ltd. (2007) Summary page 1.
- K822083: U-100 Insulin Syringe, Terumo Medical Corp. (1982) Summary page 3.
- K955235: B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1996) Summary page 3.

## Indications for use
Single use, sterile, intended use for the subcutaneous injection of U-100 Insulin only.

Source page: https://510kreport.com/device/K081547
Methodology: https://510kreport.com/methodology