Spectramed, LLC
Gahanna, OH, US
SPECTRAMED, LLC appears in FDA device records in Gahanna, OH. FDA records list 20 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Spectramed, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Selectivemed Components, Inc.510(k), recall
510(k) clearance history
FDA records hold 20 510(k) clearances for Spectramed, LLC between 1987 and 2013. The busiest year on record is 1989, with 5. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 3 |
| 1988 | 4 |
| 1989 | 5 |
| 1990 | 1 |
| 1995 | 2 |
| 2000 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2009 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K120922 | GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT | IPF | Substantially Equivalent | |
| K083756 | GUARDIAN 150 ELECTRODE | GXY | Substantially Equivalent | |
| K031053 | SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 | EGJ | Substantially Equivalent | |
| K020476 | MEDION 6000 | EGJ | Substantially Equivalent | |
| K993081 | IO-DRIVE | EGJ | Substantially Equivalent | |
| K946230 | ENDURA REUSABLE TENS AND NMES ELECTRODES | GZJ | Substantially Equivalent | |
| K945676 | GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES | GZJ | Substantially Equivalent | |
| K896122 | AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED | KXO | Substantially Equivalent | |
| K892941 | CCO SYSTEM MODEL SP1467,SP5567,SP6267 | KRB | Substantially Equivalent | |
| K895323 | MODEL DT-BAL, BALANCE SAVER | KXO | Substantially Equivalent | |
| K894362 | MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP | KXO | Substantially Equivalent | |
| K881857 | AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. | KXO | Substantially Equivalent | |
| K885235 | SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. | DSK | Substantially Equivalent | |
| K881825 | MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH | DYB | Substantially Equivalent | |
| K875337 | HEPARIN COATED LUMINAL PACING CATHETER | DQO | Substantially Equivalent | |
| K880740 | MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE | DQF | Substantially Equivalent | |
| K873168 | SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS | DRS | Substantially Equivalent | |
| K871573 | CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS | DQY | Substantially Equivalent | |
| K865101 | SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM | DXG | Substantially Equivalent | |
| K864507 | V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 | LDF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1528764 | 1000136007 | SPECTRAMED, LLC | 275 W Johnstown Rd, Gahanna, OH 43230 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DQFActuator, Syringe, Injector Type
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- EGJDevice, Iontophoresis, Other Uses
- GXYElectrode, Cutaneous
- LDFElectrode, Pacemaker, Temporary
- DYBIntroducer, Catheter
- KXOMonitor, Pressure, Intrauterine
- KRBProbe, Thermodilution
- IPFStimulator, Muscle, Powered
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- DRSTransducer, Blood-Pressure, Extravascular
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0799-05 | Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments. | The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain