510(k) · Cleared
ClearedMeddorna Wireless PRN Spirometer 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meddorna, LLC · BZG Spirometer, Diagnostic
Cleared on Apr 24, 2008 as substantially equivalent to K973138 (Qrs Diagnostic, LLC, 1998) and 1 other predicate after a 211-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Apr 24, 2008
- Review
- 211 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K963725 (1997). 9 ancestors in all, the oldest K932278 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 3 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 2 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 1 generation backK050853 PMP4 SpiroproCard Guard Scientific Survival, Ltd. · 2005
- This deviceK072722 Meddorna Wireless PRN Spirometer 100Meddorna, LLC · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −3 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −2 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −1 | K050853 | PMP4 Spiropro | Card Guard Scientific Survival, Ltd. | 2005 | — |
| 0 (this device) | K072722 | Meddorna Wireless PRN Spirometer 100 | Meddorna, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K973138 | SpirocardSummary page 1…less PRN Spirometer 100 Common Name: Spirometer Classification Name: Diagnostic Spirometer 3. Predicate Devices: SpiroCard, K973138, QRS Diagnostic, LLC and PMP4 Spiro Pro, K050853, Card Guard Scientific Survival, Ltd., Rehovot 76100, Israel. 4. Cl… | 1998 |
| * | K050853 | PMP4 SpiroproSummary page 1…Name: Spirometer Classification Name: Diagnostic Spirometer 3. Predicate Devices: SpiroCard, K973138, QRS Diagnostic, LLC and PMP4 Spiro Pro, K050853, Card Guard Scientific Survival, Ltd., Rehovot 76100, Israel. 4. Classifications Names & Citations: 21 CFR 868… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 9 ancestors has a recall.
- 2 other devices also cite its predicate K973138.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The MEDDORNA Wireless PRN Spirometer Model 100 is intended for use as a diagnostic spirometer, measuring FVC, MW and SVC breathing functions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072722 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072722: Meddorna Wireless PRN Spirometer 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072722
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026