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510(k) K042316

VANGUARD REPROCESSED PULSE OXIMETER SENSORS by Vanguard Medical Concepts, Inc. — Product Code NLF

K042316 is an FDA 510(k) premarket notification submitted by Vanguard Medical Concepts, Inc. for the device "VANGUARD REPROCESSED PULSE OXIMETER SENSORS". The FDA issued a decision of Substantially Equivalent on January 6, 2005. The device falls under product code NLF (Oximeter, Reprocessed), a Class II device regulated under 21 CFR 870.2700. Vanguard Medical Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2005
Date Received
August 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter, Reprocessed
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other clearances by Vanguard Medical Concepts, Inc.

  • K053051 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (December 22, 2005)
  • K051616 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (September 6, 2005)
  • K051180 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (July 22, 2005)
  • K051043 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (June 6, 2005)
  • K050763 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (June 1, 2005)
  • K043198 — VANGUARD REPROCESSED ARTHROSCOPIC WANDS (May 27, 2005)
  • K043253 — VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS (April 8, 2005)
  • K043594 — VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES (March 31, 2005)
  • K043225 — VANGUARD REPROCESSED ULTRASONIC SCALPEL (March 22, 2005)
  • K043315 — VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL (March 22, 2005)

Other clearances for product code NLF

  • K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pul (October 22, 2024)
  • K222019 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Puls (December 4, 2022)
  • K211138 — Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-2 (March 8, 2022)
  • K201699 — Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor (July 22, 2020)
  • K191018 — Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive (July 3, 2019)
  • K111773 — RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE (November 16, 2011)
  • K110723 — M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS (July 28, 2011)
  • K102560 — REPROCESSED PULSE OXIMETER SENSORS (February 18, 2011)
  • K101280 — MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE (October 7, 2010)
  • K092368 — REPROCESSED PULSE OXIMETER SENSORS (November 3, 2009)

FDA data resources