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510(k) K882461

O2 CARE by Ballard Medical Products — Product Code KPJ

K882461 is an FDA 510(k) premarket notification submitted by Ballard Medical Products for the device "O2 CARE". The FDA issued a decision of SN on November 28, 1988. The device falls under product code KPJ (Chamber, Oxygen, Topical, Extremity), a Class II device regulated under 21 CFR 878.5650. Ballard Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
November 28, 1988
Date Received
June 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Oxygen, Topical, Extremity
Device Class
Class II
Regulation Number
878.5650
Review Panel
SU
Submission Type

Other clearances by Ballard Medical Products

  • K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (March 31, 2003)
  • K022398 — REUSABLE BRONCHIAL BIOPSY FORCEPS (October 11, 2002)
  • K013892 — LUTZ NEEDLE (July 11, 2002)
  • K000495 — BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES (March 28, 2000)
  • K993138 — BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT (October 20, 1999)
  • K990376 — BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME (May 3, 1999)
  • K982894 — MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT (September 11, 1998)
  • K974630 — 72 HOUR USE TRACH CARE WITH MICROBAN (March 11, 1998)
  • K964369 — TRACH CARE SET WITH MICROBAN (February 11, 1997)
  • K951533 — EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (July 5, 1995)

Other clearances for product code KPJ

  • K250188 — Wound Treatment System (VHT-200) (March 10, 2025)
  • K212121 — VHT-200 Wound Treatment System (March 23, 2023)
  • K190742 — EPIFLO-28 (December 13, 2019)
  • K112634 — NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP (July 3, 2012)
  • K120764 — EPIFLO(R) (April 27, 2012)
  • K090681 — TANSCU O2 (August 12, 2009)
  • K080966 — HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM (August 6, 2008)
  • K050156 — WHS-1000 WOUND HEALING SYSTEM (June 17, 2005)
  • K023456 — OXYBOX SYSTEM (February 24, 2003)
  • K022028 — VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER (December 17, 2002)

FDA data resources