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510(k) K951697

PEDIATRIC ENDOTRACHEAL TUBE by Unomedical Sdn Bhd — Product Code BTR

K951697 is an FDA 510(k) premarket notification submitted by Unomedical Sdn Bhd for the device "PEDIATRIC ENDOTRACHEAL TUBE". The FDA issued a decision of Substantially Equivalent on May 22, 1995. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Unomedical Sdn Bhd has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1995
Date Received
April 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

Other clearances by Unomedical Sdn Bhd

  • K210544 — Medtronic Extended infusion set (July 16, 2021)
  • K192647 — neria guard Infusion Set (December 13, 2019)
  • K173879 — MiniMed Mio Advance infusion set (March 5, 2018)
  • K162812 — Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutane (November 1, 2017)
  • K160648 — MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® (August 10, 2016)
  • K132142 — NERIA SOFT 90 INFUSION SET (October 8, 2013)
  • K120337 — I-PORT ADVANCE INJECTION PORT (February 16, 2012)
  • K070430 — PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS (April 4, 2007)
  • K061374 — INTUITION INFUSION SETS (July 31, 2006)
  • K051264 — COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS (September 1, 2005)

Other clearances for product code BTR

  • K253437 — Spiro-VISTA (June 12, 2026)
  • K250173 — Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE T (October 6, 2025)
  • K243785 — Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye S (September 25, 2025)
  • K243579 — AeroJet Ventilation Catheter (August 13, 2025)
  • K251499 — Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C- (June 11, 2025)
  • K250243 — ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); (May 20, 2025)
  • K242495 — LMA Fastrach ETT SU (April 29, 2025)
  • K241451 — Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); (February 11, 2025)
  • K233341 — Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, (May 20, 2024)
  • K223130 — Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP ( (August 30, 2023)

FDA data resources