Data / Medical devices / China / Laerdal Medical (suzhou) Co., Ltd.
Laerdal Medical (suzhou) Co., Ltd.: FDA-registered device maker in 215009 Suzhou Jiangsu Province, China, 10 510(k) clearances
Laerdal Medical (suzhou) Co., Ltd. is registered with the FDA (registration 3004993040) in 215009 Suzhou Jiangsu Province, China. It lists 12 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 24, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004993040
- Address
- No.19 BLDG., Huoju RD. Science & Technology Ind. Park, 215009 Suzhou Jiangsu Province, China, --
- Owner or operator
- LAERDAL MEDICAL A/S (9038993)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- February 2, 2005
- Registered through
- 2026
- Brand names listed
- American Red Cross Face Shield, American Red Cross Pocket Mask, LAERDAL POCKET MASK, Laerdal Compact Suction Unit 4 (LCSU 4), Laerdal Face Shield, Laerdal Face Shield Key Ring, Laerdal Paediatric Pocket Mask, Laerdal Silicone Mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | 2 | Manufacturer | accessdata.fda.gov |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | 2 | Manufacturer | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Truncal/Orthosis, Limb | MRI | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Valve, Non-Rebreathing | CBP | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 24, 2025 | K251631 | The BAG manual resuscitator and accessories | BTM | Substantially Equivalent | Laerdal Medical AS | accessdata.fda.gov |
| January 15, 2015 | K132172 | NEONATALIE RESUSCITATOR | BTM | Substantially Equivalent | Laerdal Medical A/S | accessdata.fda.gov |
| April 3, 2012 | K120065 | PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES | JCX | Substantially Equivalent | Plaxtron Industrial (M) Sdn. Bhd. | accessdata.fda.gov |
| February 11, 2003 | K023805 | LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 | CBP | Substantially Equivalent | Laerdal Medical A/S | accessdata.fda.gov |
| December 20, 1999 | K993668 | LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 | BTA | Substantially Equivalent | Laerdal Medical A/S | accessdata.fda.gov |
| December 2, 1993 | K933048 | LAERDAL(TM) POCKET MASK, MODIFICATION | KGB | Substantially Equivalent | Laerdal Medical Corp. | accessdata.fda.gov |
| March 4, 1988 | K880450 | RESUSCI PATIENT FACE SHIELD | BTM | Substantially Equivalent | Laerdal Medical Corp. | accessdata.fda.gov |
| November 3, 1986 | K862875 | E-VAC(TM) | BTA | Substantially Equivalent | Laerdal California, Inc. | accessdata.fda.gov |
| May 21, 1986 | K861401 | LAERDAL POCKET MASK | CBP | Substantially Equivalent | Laerdal Medical Corp. | accessdata.fda.gov |
| November 7, 1983 | K832990 | STIFNICK IMMOBILIZING COLLAR | IQK | Substantially Equivalent | Laerdal California, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 18, 2020 | 86702 | Class II | Terminated | Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airwa | Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user. | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Suction, Ward Use, Portable, Ac-Powered
- All makers of Mask, Oxygen
- All makers of Mask, Oxygen, Non-Rebreathing
- All makers of Valve, Non-Rebreathing
- All makers of Ventilator, Emergency, Manual (Resuscitator)
- All makers of Orthosis, Cervical
Updated November 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.