# Spectra Medical Devices, Inc.

- Location (FDA's records): Wilmington, MA
- FDA decisions: 8 (2008–2017): 8 510(k) clearances
- Names in FDA's records: Spectra Medical Devices, Inc. (6); Spectra Medical Devices (2)
- Product codes: BSP (2), FMF (2), NGT (2), KNW (1), DYB (1)
- Predicates its devices cite: 9 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Excelsior Medical Corp.: 2 (https://510kreport.com/company/excelsior-medical)
- Havel'S, Inc.: 1 (https://510kreport.com/company/havel-s)
- Medical Device Technologies, Inc.: 1 (https://510kreport.com/company/medical-device-technologies)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Pajunk GmbH: 1 (https://510kreport.com/company/pajunk)
- Avid Medical, Inc.: 1 (https://510kreport.com/company/avid-medical)
- Teleflexmedical, Inc.: 1 (https://510kreport.com/company/teleflexmedical)

## Firms that cite its devices most
- Artiglass Srl: 1 (https://510kreport.com/company/artiglass)
- Intervene Group Limited: 1 (https://510kreport.com/company/intervene-group)

## Its most-cited devices
- K082674: Spectra-Glass Lor (Loss of Resistance Syringe, 5CC Metal L/S or L/L Tip, Spectra-Glass Lor (Loss of Resistance) Syringe (2008), cited by 1
- K081524: Spectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S, Spectra-Lor, 10ML Plastic Loss of Resistance Syringe L/L (2008), cited by 1
- K082689: Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, Ampule (2009), cited by 1

## Recent decisions
- K163292: Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford (Sep 8, 2017)
- K151069: SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle (Feb 5, 2016)
- K142791: Spectra Soft Tissue Biopsy Needles (Jan 21, 2015)
- K103740: Sodium Chloride Injection, 0.9%, Usp 5 ML, 10 ML Ampule (Jul 29, 2011)
- K082689: Sterile Sodium Chloride 0.9% Flush, 5ML, 10ML, Ampule (Mar 20, 2009)
- K082580: Spectra Guidewire Introducer Needle (Dec 8, 2008)
- K082674: Spectra-Glass Lor (Loss of Resistance Syringe, 5CC Metal L/S or L/L Tip, Spectra-Glass Lor (Loss of Resistance) Syringe (Nov 28, 2008)
- K081524: Spectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S, Spectra-Lor, 10ML Plastic Loss of Resistance Syringe L/L (Jul 29, 2008)

Source page: https://510kreport.com/company/spectra-medical-devices