GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
FDA 510(k) clearance K020418 · decided 2003-04-29
Clearance details
- K-number
- K020418
- Device name
- GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
- Applicant
- P.T. Greenleaf
- Decision
- Substantially Equivalent
- Date received
- 2002-02-07
- Decision date
- 2003-04-29
- Days to decision
- 446 days
- Clearance type
- Traditional
- Product code
- MEA
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Perth, AU
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump (K162165) | Summit Medical Products, Inc. | 2017-08-29 |
| CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) (K170982) | Smiths Medical Ads, Inc. | 2017-08-24 |
| LifeCare PCA Infusion System (K143612) | Hospira, Inc. | 2016-04-08 |
| CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 (K130394) | Smiths Medical Asd, Inc. | 2013-12-09 |
| PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM (K092313) | B.Braun Medical, Inc. | 2009-11-04 |
| CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR (K072144) | Smiths Medical MD, Inc. | 2008-03-07 |
| MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) (K051253) | Baxter Healthcare Corp | 2005-07-15 |
| MEDLEY PCA MODULE, MODEL 8120 (K043299) | Alaris Medical Systems, Inc. | 2004-12-10 |
| HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 (K043256) | Hospira, Inc. | 2004-12-06 |
| LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K042800) | Hospira, Inc. | 2004-10-18 |
| HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP (K033054) | Harvard Clinical Technology | 2003-12-16 |
| MEDLEY PCA MODULE, MODEL 8120 (K032233) | Alaris Medical Systems, Inc. | 2003-09-09 |
Recalls involving this device
No recalls on record reference this clearance.