Data / Medical devices / United States / Spectra Medical Devices, LLC
Spectra Medical Devices, LLC: FDA-registered device maker in Wilmington, MA, United States, 15 510(k) clearances
Spectra Medical Devices, LLC is registered with the FDA (registration 1224960) in Wilmington, MA, United States. It lists 21 device types. The FDA files 15 510(k) clearances under its listings, the newest dated September 8, 2017. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1224960
- FEI number
- 3000204727
- Address
- 299 Ballardvale St Ste 1, Wilmington, MA, United States, 01887
- Owner or operator
- SPECTRA MEDICAL DEVICES, LLC (9012618)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 13, 2008
- Registered through
- 2026
- Brand names listed
- Atraumatic Pencil Point Spinal Needle, Cervical Regional Anesthesia Needle, Disposable Epidural Anesthesia Tray, Disposable Scalpel, One-Piece, Non-Sterile, Epidural Anesthesia Needle, Glass LOR Syringe, Instrument,Manual,Surgical, General, Introducer Needle and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2017 | K163292 | Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford | BSP | Substantially Equivalent | Spectra Medical Devices | accessdata.fda.gov |
| February 5, 2016 | K151069 | SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle | BSP | Substantially Equivalent | Spectra Medical Devices, Inc. | accessdata.fda.gov |
| January 21, 2015 | K142791 | Spectra Soft Tissue Biopsy Needles | KNW | Substantially Equivalent | Spectra Medical Devices | accessdata.fda.gov |
| July 29, 2011 | K103740 | SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE | NGT | Substantially Equivalent | Spectra Medical Devices, Inc. | accessdata.fda.gov |
| December 15, 2009 | K091462 | SPECTRA MEDICAL SAFETY SCAPEL | GDZ | Substantially Equivalent | Spectra, Inc. | accessdata.fda.gov |
| December 8, 2008 | K082580 | SPECTRA GUIDEWIRE INTRODUCER NEEDLE | DYB | Substantially Equivalent | Spectra Medical Devices, Inc. | accessdata.fda.gov |
| November 28, 2008 | K082674 | SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE | FMF | Substantially Equivalent | Spectra Medical Devices, Inc. | accessdata.fda.gov |
| October 9, 2003 | K032196 | NBD DISPOSABLE RF CANNULAE | GXI | Substantially Equivalent | New Business Development, LLC | accessdata.fda.gov |
| April 13, 2000 | K000117 | AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE | HEE | Substantially Equivalent | Avid Medical, Inc. | accessdata.fda.gov |
| August 1, 1997 | K971645 | REGANES SPINAL NEEDLE (VARIOUS) | MIA | Substantially Equivalent | Avid N.I.T., Inc. | accessdata.fda.gov |
| August 2, 1995 | K945965 | ATRAUMATIC PENCIL POINT SPINAL NEEDLE | BSP | Substantially Equivalent | Avid N.I.T., Inc. | accessdata.fda.gov |
| May 30, 1989 | K891226 | VASCULAR ACCESS PORT CONTINUOUS INFUSION SET | FPA | Substantially Equivalent | Infucare Products, Inc. | accessdata.fda.gov |
| January 30, 1989 | K884792 | VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES | FMI | Substantially Equivalent | Infucare Products, Inc. | accessdata.fda.gov |
| February 11, 1988 | K880181 | REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY | CAZ | Substantially Equivalent | Reganes, Inc. | accessdata.fda.gov |
| December 19, 1985 | K854816 | EPIDURAL ANESTHESIA NEEDLES | BSP | Substantially Equivalent | Reganes, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 6, 2026 | 98777 | Class I | Ongoing | Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular acces | Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure. | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Needle, Spinal, Short Term
- All makers of Syringe, Piston
- All makers of Probe, Radiofrequency Lesion
- All makers of Generator, Lesion, Radiofrequency
- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
Updated August 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.