Home / 510(k) Clearances / K150093

510(k) K150093

Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 by Shenzhen Creative Industry Co., Ltd. — Product Code DQA

K150093 is an FDA 510(k) premarket notification submitted by Shenzhen Creative Industry Co., Ltd. for the device "Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1". The FDA issued a decision of Substantially Equivalent on Jun 3, 2015. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shenzhen Creative Industry Co., Ltd. has 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 3, 2015
Date Received
Jan 16, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type
510(k)

Other clearances by Shenzhen Creative Industry Co., Ltd.

  • K201468 — Pulse Oximeter (Jan 25, 2021)
  • K192343 — Patient Monitor (Dec 31, 2019)
  • K172792 — Handheld Pulse Oximeter, Model SP-20 (Nov 13, 2018)
  • K170047 — All-in-One Health Monitor, PC-303 (Sep 9, 2017)
  • K123711 — PATIENT MONITOR (Oct 1, 2013)
  • K120502 — PC-60NW FINGERTIP OXIMETER (Dec 7, 2012)
  • K093016 — VITAL SIGNS MONITOR (Mar 30, 2010)
  • K082055 — MODEL PC-860 FETAL DOPPLER (Feb 6, 2009)
  • K073152 — PC-180 / PRINCE 180 EASY ECG MONITOR (Jan 10, 2008)
  • K063641 — PC-60, NON-INVASIVEPULSE OXIMETER (Jul 13, 2007)

Other clearances for product code DQA

  • K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor… (May 29, 2026)
  • K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT… (May 11, 2026)
  • K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391)… (May 1, 2026)
  • K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) (Apr 14, 2026)
  • K252448 — AViTA Pulse Oximeter (SP61) (Feb 27, 2026)
  • K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (Feb 17, 2026)
  • K253109 — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (Jan 7, 2026)
  • K251751 — Spo2 Sensor CSS032D (Dec 19, 2025)
  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2… (Dec 1, 2025)
  • K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed… (Dec 1, 2025)

FDA data resources