FDA product code · Anesthesiology
BSZGas-Machine, Anesthesia
Product code BSZ covers Gas-Machine, Anesthesia, a Class II device regulated under 21 CFR 868.5160. FDA has cleared 189 devices in this code, 2 of them in the last 12 months. Median review time across the 189 most recent decisions is 111 days. openFDA lists 173 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 868.5160
- Review panel
- Anesthesiology
- Clearances
- 189
What is happening in BSZ right now?
BSZ (Gas-Machine, Anesthesia) has one finding. 5 recalls opened in the last 12 months and not yet terminated (Class I) (Z-2860-2026, Z-2207-2026, Z-2208-2026, Z-0913-2026, Z-0914-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-2860-2026, Z-2207-2026, Z-2208-2026, Z-0913-2026, Z-0914-2026 |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in BSZ?
FDA has cleared 189 devices under product code BSZ since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | |
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Drägerwerk AG Co. Kgaa | |
| K251352 | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) | Codonics.Incorporated | |
| K230931 | Atlan | Drägerwerk AG Co. Kgaa | |
| K213867 | Carestation 750/750c | Datex-Ohmeda, Inc. | |
| K201957 | A8, A9 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | Maquet Critical Care AB | |
| K171311 | A5 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | |
| K171292 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 | Datex-Ohmeda, Inc. |
How long does FDA review take for BSZ?
The median FDA review time for BSZ is 111 days, measured across the 189 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in BSZ?
openFDA lists 173 recall records against product code BSZ. A recall record covers one firm's corrective action and may span many device lots.
Z-2860-2026Open, ClassifiedMaquet Critical Care AB
Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.
Z-2207-2026Open, ClassifiedDraeger, Inc.
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Z-2208-2026Open, ClassifiedDraeger, Inc.
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Z-0913-2026Open, ClassifiedGE Medical Systems China Co., Ltd.
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
Z-0914-2026Open, ClassifiedGE Medical Systems China Co., Ltd.
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
Showing the 5 most recently initiated of 173. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for BSZ?
MAUDE holds 21,357 adverse-event reports naming product code BSZ, 5,788 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in BSZ unusual?
2 months sit above BSZ's own expected range: 1 April 2025, 1 May 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 346 | Insufficient history | No expected range — too little history | |
| 361 | Insufficient history | No expected range — too little history | |
| 436 | Insufficient history | No expected range — too little history | |
| 372 | Insufficient history | No expected range — too little history | |
| 413 | Insufficient history | No expected range — too little history | |
| 448 | Insufficient history | No expected range — too little history | |
| 373 | Insufficient history | No expected range — too little history | |
| 567 | Insufficient history | No expected range — too little history | |
| 504 | Insufficient history | No expected range — too little history | |
| 479 | Insufficient history | No expected range — too little history | |
| 470 | Insufficient history | No expected range — too little history | |
| 477 | Insufficient history | No expected range — too little history | |
| 488 | Insufficient history | No expected range — too little history | |
| 497 | Insufficient history | No expected range — too little history | |
| 494 | Insufficient history | No expected range — too little history | |
| 554 | Insufficient history | No expected range — too little history | |
| 570 | Insufficient history | No expected range — too little history | |
| 481 | Insufficient history | No expected range — too little history | |
| 546 | Insufficient history | No expected range — too little history | |
| 496 | Insufficient history | No expected range — too little history | |
| 515 | Insufficient history | No expected range — too little history | |
| 383 | 424–512 | Below expected (424–512) | |
| 351 | 324–446 | Within expected (324–446) | |
| 465 | 342–498 | Within expected (342–498) | |
| 741 | 368–529 | Above expected (368–529) | |
| 1,231 | 336–668 | Above expected (336–668) | |
| 991 | 255–1,241 | Within expected (255–1,241) | |
| 1,085 | 417–2,164 | Within expected (417–2,164) | |
| 876 | 270–1,587 | Within expected (270–1,587) | |
| 716 | 266–1,654 | Within expected (266–1,654) | |
| 874 | 205–1,557 | Within expected (205–1,557) | |
| 659 | 194–1,390 | Within expected (194–1,390) | |
| 799 | 187–1,480 | Within expected (187–1,480) | |
| 561 | 227–1,670 | Within expected (227–1,670) | |
| 791 | 98–1,310 | Within expected (98–1,310) | |
| 770 | 181–1,423 | Within expected (181–1,423) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in BSZ.
What are the predicate devices in BSZ?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in BSZ?
Across the 189 most recent decisions, these applicants filed most often in BSZ.
| Applicant | Recent clearances |
|---|---|
| Draeger Medical, Inc. | 33 |
| Datex-Ohmeda, Inc. | 20 |
| Ohmeda Medical | 17 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 6 |
| GE Healthcare Finland Oy | 5 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in BSZ file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Draeger Medical, Inc. | 35 | 2 |
| Datex-Ohmeda, Inc. | 25 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch BSZ
Get an email the morning anything changes in BSZ — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Anesthesiology
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.