Ballard Medical Products
Draper, UT, US
Ballard Medical Products appears in FDA device records in Draper, UT. FDA records list 26 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 7 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for Ballard Medical Products between 1982 and 2003. The busiest year on record is 1987, with 4. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1986 | 1 |
| 1987 | 4 |
| 1988 | 3 |
| 1989 | 2 |
| 1990 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K030721 | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE | LRO | Substantially Equivalent | |
| K022398 | REUSABLE BRONCHIAL BIOPSY FORCEPS | BWH | Substantially Equivalent | |
| K013892 | LUTZ NEEDLE | BSP | Substantially Equivalent | |
| K000495 | BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES | BSP | Substantially Equivalent | |
| K993138 | BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT | KNT | Substantially Equivalent | |
| K990376 | BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME | KNS | Substantially Equivalent | |
| K982894 | MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT | KNT | Substantially Equivalent | |
| K974630 | 72 HOUR USE TRACH CARE WITH MICROBAN | CAH | Substantially Equivalent | |
| K964369 | TRACH CARE SET WITH MICROBAN | BSY | Substantially Equivalent | |
| K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | KDH | Substantially Equivalent | |
| K923487 | BAL CATH | KTR | Unknown | |
| K915109 | RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET | FPA | Substantially Equivalent | |
| K900273 | TRACH CARE MDI ADAPTER | CAF | Substantially Equivalent | |
| K895360 | C.P.A.P. VALVE AND C.P.P.A. KIT | BYE | Substantially Equivalent | |
| K895130 | HEIMLICH MICRO TRACH | BTO | Substantially Equivalent | |
| K882461 | O2 CARE | KPJ | Substantially Equivalent for Some Indications | |
| K881790 | SAFETY DRAIN | BYH | Substantially Equivalent | |
| K873731 | SAFETY SHIELD KIT | FXX | Substantially Equivalent | |
| K873810 | SAFETY SHIELD SUCTION CATHETER | BSY | Substantially Equivalent | |
| K873732 | TRACH CARE START KIT | BSY | Substantially Equivalent | |
| K872621 | TRACH CARE CATHETER | BSY | Substantially Equivalent | |
| K872283 | ORAL SUCTION CATHETER | BSY | Substantially Equivalent | |
| K860510 | NEONATE PERCUSSOR | BYI | Substantially Equivalent | |
| K843636 | FOAM CARE ONE STEP PREP | GEC | Substantially Equivalent | |
| K831226 | MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450 | GEC | Substantially Equivalent | |
| K820713 | BALLARD MEDICAL PRODUCTS ELECTRO-SURG | GEI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- GECBrush, Scrub, Operating-Room
- KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
- BSYCatheters, Suction, Tracheobronchial
- KPJChamber, Oxygen, Topical, Extremity
- BYHDrain, Tee (Water Trap)
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- CAHFilter, Bacterial, Breathing-Circuit
- BWHForceps, Biopsy, Bronchoscope (Non-Rigid)
- LROGeneral Surgery Tray
- FXXMask, Surgical
- CAFNebulizer (Direct Patient Interface)
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- BYIPercussor, Powered-Electric
- FPASet, Administration, Intravascular
- KTRTube, Aspirating, Bronchoscope, Rigid
- BTOTube, Tracheostomy (W/Wo Connector)
- KNTTubes, Gastrointestinal (And Accessories)
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1085-03 | Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. For distribution to Germany only. | Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases. | Terminated | ||
| Z-1084-03 | Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. For international distribution only. | Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases. | Terminated | ||
| Z-1083-03 | Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates | Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases. | Terminated | ||
| Z-1082-03 | Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates | Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases. | Terminated | ||
| Z-1081-03 | Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates | Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases. | Terminated | ||
| Z-1080-03 | Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates | Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases. | Terminated | ||
| Z-1079-03 | Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. | Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain