# Bioject, Inc.

- Location (FDA's records): Portland, OR
- FDA decisions: 9 (1987–2009): 9 510(k) clearances
- Product codes: KZE (7), LHI (2)
- Predicates its devices cite: 7 (3 its own); citations of its devices by later devices: 21 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medi-Ject Corp.: 1 (https://510kreport.com/company/medi-ject)
- Vitajet Corp.: 1 (https://510kreport.com/company/vitajet)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)

## Firms that cite its devices most
- Medical House Products Limited: 4 (https://510kreport.com/company/medical-house-products)
- Bioject Medical Technologies, Inc.: 3 (https://510kreport.com/company/bioject-medical-technologies)
- Avant Medical Corporation: 3 (https://510kreport.com/company/avant-medical)
- Biovalve Technologies, Inc.: 2 (https://510kreport.com/company/biovalve-technologies)
- Medi-Ject Corp.: 1 (https://510kreport.com/company/medi-ject)
- D'Antonio Consultants International, Inc. (Dci): 1 (https://510kreport.com/company/d-antonio-consultants-international-dci)
- Pharmajet, Inc.: 1 (https://510kreport.com/company/pharmajet)
- Duoject Medical Systems, Inc.: 1 (https://510kreport.com/company/duoject-medical-systems)

## Its most-cited devices
- K960373: Biojector 2000 Model 1B02000 (1997), cited by 7
- K920631: Bioject Jet Injection System (1994), cited by 4
- K994384: Clicker (2000), cited by 3
- K963012: Bioject Needle-Free Vial Adapter (13MM) (1996), cited by 3
- K010623: Reconstitution Kit & Vial Connector (2001), cited by 2
- K050734: Cool.Click (2005), cited by 1

## Recent decisions
- K090003: Zetajet (Apr 2, 2009)
- K050734: Cool.Click (Jun 3, 2005)
- K010623: Reconstitution Kit & Vial Connector (Apr 5, 2001)
- K003908: Serojet (Mar 8, 2001)
- K994384: Clicker (Jun 22, 2000)
- K960373: Biojector 2000 Model 1B02000 (Mar 5, 1997)
- K963012: Bioject Needle-Free Vial Adapter (13MM) (Oct 15, 1996)
- K920631: Bioject Jet Injection System (Jun 28, 1994)

Source page: https://510kreport.com/company/bioject