Company ยท US
Laerdal Medical Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2025. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (1 in 12 months)
8recalls (1 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 7 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 4 |
| LIX | Aid, Cardiopulmonary Resuscitation | 3 |
| BSR | Stylet, Tracheal Tube | 2 |
| CBP | Valve, Non-Rebreathing | 2 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| KGB | Mask, Oxygen, Non-Rebreathing | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 24, 2025 | K251631 | The BAG manual resuscitator and accessories Laerdal Medical AS, NO | BTM |
| Jun 25, 2024 | K232111 | NeoBeat, NeoBeat Mini Laerdal Medical AS, NO | MWI |
| Dec 17, 2018 | K183348 | Reusable Silicone Cover CPRmeter 2 Laerdal Medical AS, NO | LIX |
| Mar 23, 2018 | K173886 | CPRmeter 2 CPR Feedback Device Laerdal Medical AS, NO | LIX |
| Aug 13, 2015 | K151702 | Reusable Full Silicone Cover Laerdal Medical AS, NO | LIX |
| Oct 6, 2000 | K001742 | RESUSCI INFLATE-A-SHIELD CPR BARRIER Laerdal Medical Corp. | CBP |
| Sep 5, 1996 | K962361 | TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND Laerdal Medical Corp. | BSR |
| May 9, 1996 | K954771 | TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) Laerdal Medical Corp. | BSR |
| Jan 4, 1996 | K954609 | HEARTSTART 911 Laerdal Medical Corp. | MKJ |
| May 9, 1995 | K950698 | LSU 2000 PORTABLE SUCTION UNIT Laerdal Medical Corp. | JCX |
| Dec 2, 1993 | K933048 | LAERDAL(TM) POCKET MASK, MODIFICATION Laerdal Medical Corp. | KGB |
| May 3, 1990 | K896919 | HEARTSTART 3000 Laerdal Medical Corp. | MKJ |
| Mar 4, 1988 | K880450 | RESUSCI PATIENT FACE SHIELD Laerdal Medical Corp. | BTM |
| May 21, 1986 | K861401 | LAERDAL POCKET MASK Laerdal Medical Corp. | CBP |
| Mar 12, 1984 | K840110 | LAERDAL SUCTION UNIT Laerdal Medical Corp. | BTA |
| Aug 20, 1982 | K822356 | MODULAIDE EMERG. CARDIAC LIFE SUPP. KT Laerdal Medical Corp. | BTM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2026 | Laerdal Medical Corporation Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA)
1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052;
2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062;
3) LCSU 4, RTCA; Catalog Number: 881152; Open, Classified |
JCX | K120065 |
| Aug 31, 2017 | Laerdal Medical Corporation LCSU 4, Laerdal Compact Suction Unit
The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove Terminated |
JCX | K120065 |
| Jan 8, 2017 | Laerdal Medical Corporation Laerdal Compact Suction Unit 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit ( Terminated |
JCX | None listed |
| May 12, 2005 | Laerdal Medical Corporation LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Phil Terminated |
LDD | None listed |
| Feb 10, 2004 | Laerdal Medical Corporation Intake/Reservoir Valve (Part No. 875400), used in all sizes of Laerdal Silicone Resuscitators. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, Terminated |
BTM | None listed |
| Feb 10, 2004 | Laerdal Medical Corporation LAERDAL Silicone Resuscitator (LSR), Preterm Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 850050-Preterm Basic w/o Mask in Carton; 850051-Preterm Complete in Carton; 850053-Preterm Terminated |
BTM | None listed |
| Feb 10, 2004 | Laerdal Medical Corporation LAERDAL Silicone Resuscitator (LSR), Pediatric Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 860050-Pediatric Basic w/o Mask in Carton; 860051-Pediatric Complete in Carton; 860052-St Terminated |
BTM | None listed |
| Feb 10, 2004 | Laerdal Medical Corporation LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold as Part Nos: 870050-Adult Basic w/o Mask in Carton; 870051-Adult Complete in Carton; 870052-Adult Standard wi Terminated |
BTM | None listed |