Company
Draeger, Inc.
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)
22recalls (9 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OFP | Anesthesia Breathing Circuit Kit (Adult & Pediatric) | 5 |
| BSZ | Gas-Machine, Anesthesia | 4 |
| BZA | Connector, Airway (Extension) | 4 |
| CAH | Filter, Bacterial, Breathing-Circuit | 4 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 |
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) |
|---|---|---|---|
| Oct 1, 2026 | Draeger, Inc. VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310
Disposable breathing circuit for use with a resuscitation module. Open, Classified |
BYE | K092029 |
| Jun 4, 2026 | Draeger, Inc. Atlan A350XL. Model Number: 8621600. anesthesia workstation Open, Classified |
BSZ | K230931 |
| Jun 4, 2026 | Draeger, Inc. Atlan A350. Model Number: 8211500. anesthesia workstation Open, Classified |
BSZ | K230931 |
| Dec 23, 2025 | Draeger, Inc. Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. Open, Classified |
CAD | K971923 |
| Dec 23, 2025 | Draeger, Inc. Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer. Open, Classified |
CAD | K971923 |
| Dec 8, 2025 | Draeger, Inc. ErgoStar CM 60,
Model/Catalog Number: MP01860,
Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mech Open, Classified |
BZA | None listed |
| Dec 8, 2025 | Draeger, Inc. ErgoStar CM 55,
Model/Catalog Number: MP01855,
Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mech Open, Classified |
BZA | None listed |
| Dec 8, 2025 | Draeger, Inc. ErgoStar CM 45,
Model/Catalog Number: MP01845,
Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mecha Open, Classified |
BZA | None listed |
| Dec 8, 2025 | Draeger, Inc. ErgoStar CM 40
Model/Catalog Number: MP01840
Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanic Open, Classified |
BZA | None listed |
| Oct 1, 2025 | Draeger, Inc. Brand Name: Atlan
Product Name: Atlan A350XL
Model/Catalog Number: 8621600
Software Version: Not Applicable
Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizin Open, Classified |
BSZ | K230931 |
| Oct 1, 2025 | Draeger, Inc. Brand Name: Atlan
Product Name: Atlan A350
Model/Catalog Number: 8211500
Software Version: Not applicable
Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing Open, Classified |
BSZ | K230931 |
| Jul 31, 2025 | Draeger, Inc. SafeStar 60A Plus Filter. Bidirectionally breathing system filter. Open, Classified |
CAH | K221836 |
| Jul 31, 2025 | Draeger, Inc. HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter. Open, Classified |
CAH | K221836 |
| Jul 31, 2025 | Draeger, Inc. SafeStar 55 Plus Filter. Bidirectionally breathing system filter. Open, Classified |
CAH | K221836 |
| Jul 31, 2025 | Draeger, Inc. SafeStar 90 Plus Filter. Bidirectionally breathing system filter. Open, Classified |
CAH | K221836 |
| Apr 3, 2025 | Draeger, Inc. Brand Name: Anesthesia Circuit Kit
Product Name: Anesthesia Circuit Kit Flex EPA
Model/Catalog Number: MP17103
Software Version: Not applicable
Product Description: Accessory for conducting medical ga Open, Classified |
OFP | None listed |
| Apr 3, 2025 | Draeger, Inc. Brand Name: Anesthesia Circuit Kit
Product Name: Anesthesia Circuit Kit Flex (P)2
Model/Catalog Number: MP02752
Software Version: Not applicable
Product Description: Accessory for conducting medical g Open, Classified |
OFP | None listed |
| Apr 3, 2025 | Draeger, Inc. Brand Name: Anesthesia Circuit Kit
Product Name: Anesthesia Circuit Kit Flex 6
Model/Catalog Number: MP02744
Software Version: Not applicable
Product Description: Accessory for conducting medical gase Open, Classified |
OFP | None listed |
| Apr 3, 2025 | Draeger, Inc. Brand Name: Anesthesia Circuit Kit
Product Name: Anesthesia Circuit Kit Flex 2
Model/Catalog Number: MP02738
Software Version: Not applicable
Product Description: Accessory for conducting medical gase Open, Classified |
OFP | None listed |
| Apr 3, 2025 | Draeger, Inc. Brand Name: Anesthesia Circuit Kit
Product Name: Anesthesia Circuit Kit Flex 1
Model/Catalog Number: MP02737
Software Version: Not applicable
Product Description: Accessory for conducting medical gase Open, Classified |
OFP | None listed |
| Apr 3, 2025 | Draeger, Inc. Brand Name: ID Circuit
Product Name: ID Circuit Flex 220
Model/Catalog Number: MP01347
Software Version: Not applicable
Product Description: Breathing circuit for conveying breathing gases between an Open, Classified |
BZO | None listed |
| Apr 3, 2025 | Draeger, Inc. Brand Name: VentStar
Product Name: VentStar Flex 220
Model/Catalog Number: MP00355
Software Version: Not applicable
Product Description: Breathing circuit for conveying breathing gases between an anes Open, Classified |
CAI | None listed |