FDA product code · Anesthesiology
BZGSpirometer, Diagnostic
Product code BZG covers Spirometer, Diagnostic, a Class II device regulated under 21 CFR 868.1840. FDA has cleared 228 devices in this code, 1 of them in the last 12 months. Median review time across the 228 most recent decisions is 144 days. openFDA lists 1 recall record against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 868.1840
- Review panel
- Anesthesiology
- Clearances
- 228
What is happening in BZG right now?
BZG (Spirometer, Diagnostic) has two findings, most consequential first. 1 first-time filer in the last 12 months, Mesi D.O.O (K251777). The code is crowded, scoring 67 of 100 — 125 companies hold a clearance here and 1 arrived in the last 12 months (BZG:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K251777 |
| Crowding | Context | BZG:crowding |
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 BZG?
FDA has cleared 228 devices under product code BZG since the 510(k) programme began in 1976, 1 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251777 | MESI mTABLET SPIRO | Mesi D.O.O. | |
| K241843 | TD-7301 Spirometer (TD-7301) | Gostar Co., Ltd. | |
| K231416 | Air Next (NVD-02) | Nuvoair AB | |
| K230501 | Spirobank Oxi | Mir Medical International Research USA | |
| K230178 | EasyOne Sky Spirometer | Ndd Medizintechnik AG | |
| K222525 | Alveoair Digital Spirometer | Roundworks Technologies Private Limited | |
| K222443 | Air Smart Extra Spirometer | Feellife Health, Inc. | |
| K213754 | SpiroHome Personal, SpiroHome Clinic | Inofab Saglik Teknolojileri A.S | |
| K213872 | ComPAS2 | Morgan Scientific, Inc. | |
| K212938 | Vitalograph Model 6000 Alpha | Vitalograph Ireland, Ltd. |
How long does FDA review take for BZG?
The median FDA review time for BZG is 144 days, measured across the 228 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 BZG?
openFDA lists 1 recall record against product code BZG. A recall record covers one firm's corrective action and may span many device lots.
Z-0324-2025Open, ClassifiedBaxter Healthcare Corporation
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
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 BZG?
MAUDE holds 6 adverse-event reports naming product code BZG.
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 BZG unusual?
BZG does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
6 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.
Who has entered BZG in the last year?
One company filed in BZG for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Mesi D.O.O. | K251777 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in BZG?
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 BZG?
Across the 228 most recent decisions, these applicants filed most often in BZG.
| Applicant | Recent clearances |
|---|---|
| Mir Medical Intl. Research Srl | 9 |
| Sdi Diagnostics, Inc. | 8 |
| Vitalograph (Ireland) , Ltd. | 6 |
| Future Impex Corp. | 5 |
| Medical Equipment Designs, Inc. | 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 BZG 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 |
|---|---|---|
| Vitalograph (Ireland) , Ltd. | 9 | 2 |
| Vitalograph , Ltd. | 7 | 2 |
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 BZG
Get an email the morning anything changes in BZG — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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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.