ClearanceBrief
Company

SunMed Holdings, LLC

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
18recalls (4 in 12 months)
11recalls that name a 510(k)

Product codes

CodeDeviceRecords
BTMVentilator, Emergency, Manual (Resuscitator)10
OKIEmergency Response Safety Kit5
CAEAirway, Oropharyngeal, Anesthesiology2
CBTArterial Blood Sampling Kit1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 28, 2026SunMed Holdings, LLC
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-ba
Open, Classified
OKINone listed
Jan 28, 2026SunMed Holdings, LLC
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weigh
Open, Classified
OKINone listed
Jan 28, 2026SunMed Holdings, LLC
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weigh
Open, Classified
OKINone listed
Jan 28, 2026SunMed Holdings, LLC
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weig
Open, Classified
OKINone listed
Jun 20, 2025SunMed Holdings, LLC
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based refere
Open, Classified
OKINone listed
May 30, 2025SunMed Holdings, LLC
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Open, Classified
BTMK953546
Nov 21, 2023SunMed Holdings, LLC
Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM1116MC, CPRM1116PM, CPRM
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care In
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resuscitator REF #: SC9101B; 2. STAT-Check Infant Resuscita
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, SS3
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F;
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P; 2. BreathTech Child
Open, Classified
BTMK012842
Nov 21, 2023SunMed Holdings, LLC
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF
Open, Classified
BTMK012842
Jan 26, 2023SunMed Holdings, LLC
AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0
Open, Classified
CAENone listed
Jan 26, 2023SunMed Holdings, LLC
Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0
Open, Classified
CAENone listed
Sep 23, 2022SunMed Holdings, LLC
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Terminated
CBTK944941
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