Promedic, Inc.
Mccordsville, IN, US
Promedic, Inc. appears in FDA device records in Mccordsville, IN. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Promedic, Inc. between 1995 and 2014. The busiest year on record is 1995, with 3. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 3 |
| 1996 | 1 |
| 1997 | 2 |
| 2002 | 1 |
| 2003 | 3 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K131889 | EUM 100PRO | OSP | Substantially Equivalent | |
| K112318 | CLEARPATH 24 | OCX | Substantially Equivalent | |
| K072756 | NON-IV ADAPTER FOR INFANT NG TUBE | KNT | Unknown | |
| K060497 | BABYAIR | CAF | Substantially Equivalent | |
| K060842 | REVJET TURBO | CAF | Substantially Equivalent | |
| K052903 | PEDIATRIC FEEDING TUBE | KNT | Substantially Equivalent | |
| K031409 | URINARY CATHETERS | GBM | Substantially Equivalent | |
| K024190 | FENESTRATED INFUSION CATHETER | FRN | Substantially Equivalent | |
| K023579 | GAS SAMPLING LINES | CCK | Substantially Equivalent | |
| K020005 | INFANT FEEDING TUBES | KNT | Substantially Equivalent | |
| K970102 | FILTER | CAH | Substantially Equivalent | |
| K970991 | DATEX ENGSTOM MANUAL RESUSCITATOR | BTM | Unknown | |
| K962182 | BURLEW INFANT HOOD | FOG | Substantially Equivalent | |
| K954201 | BUONAFEDE PNEUMATIC SLEEVE | KCY | Substantially Equivalent | |
| K951988 | PRESSURIZER | KZD | Substantially Equivalent | |
| K951043 | AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK | BSJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- GBMCatheter, Urethral
- OCXEndoscopic Irrigation/Suction System
- CAHFilter, Bacterial, Breathing-Circuit
- FOGHood, Oxygen, Infant
- KZDInfusor, Pressure, For I.V. Bags
- BSJMask, Gas, Anesthetic
- CAFNebulizer (Direct Patient Interface)
- FRNPump, Infusion
- KCYTourniquet, Pneumatic
- KNTTubes, Gastrointestinal (And Accessories)
- OSPUterine Electromyographic Monitor
- BTMVentilator, Emergency, Manual (Resuscitator)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain