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510(k) K885243

NEOVO2R VENTILATORY by Neomed — Product Code BTM

K885243 is an FDA 510(k) premarket notification submitted by Neomed for the device "NEOVO2R VENTILATORY". The FDA issued a decision of Substantially Equivalent on July 24, 1989. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Neomed has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1989
Date Received
December 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

Other clearances by Neomed

  • K183540 — Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/E (April 30, 2019)
  • K161039 — NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoC (June 17, 2016)
  • K152857 — NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure (December 17, 2015)
  • K143344 — NeoMed NeoConnect Enteral Syringes with ENFit Connector (April 9, 2015)
  • K122373 — NEOMED ORAL/ENTERAL SYRINGE (September 20, 2012)
  • K120182 — NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES (April 19, 2012)
  • K100288 — NEOMED ENTERAL ONLY EXTENSION SET (August 3, 2010)
  • K092908 — NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD (March 10, 2010)
  • K082238 — NEOMED POLYURETHANE FEEDING TUBE (October 1, 2008)
  • K081515 — NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 (July 21, 2008)

Other clearances for product code BTM

  • K251631 — The BAG manual resuscitator and accessories (November 24, 2025)
  • K243861 — butterflyBVM (April 25, 2025)
  • K221841 — EOlife® (March 18, 2023)
  • K212905 — Sotair Device (August 18, 2022)
  • K210288 — Disposable Manual Resuscitator (August 26, 2021)
  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (December 7, 2018)
  • K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremoun (May 11, 2018)
  • K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR (August 29, 2016)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K112852 — BABI PLUS NEONATAL RESUSCITATION BAG (January 13, 2012)

FDA data resources