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
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2026 | SunMed 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 |
OKI | None listed |
| Jan 28, 2026 | SunMed 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 |
OKI | None listed |
| Jan 28, 2026 | SunMed 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 |
OKI | None listed |
| Jan 28, 2026 | SunMed 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 |
OKI | None listed |
| Jun 20, 2025 | SunMed 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 |
OKI | None listed |
| May 30, 2025 | SunMed Holdings, LLC Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F Open, Classified |
BTM | K953546 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Nov 21, 2023 | SunMed 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 |
BTM | K012842 |
| Jan 26, 2023 | SunMed 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 |
CAE | None listed |
| Jan 26, 2023 | SunMed 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 |
CAE | None listed |
| Sep 23, 2022 | SunMed Holdings, LLC Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH,
REF Number 3373-91 Terminated |
CBT | K944941 |