510(k) · Cleared
ClearedPMP4 Spiropro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Card Guard Scientific Survival, Ltd. · BZH Meter, Peak Flow, Spirometry
Cleared on May 4, 2005 as substantially equivalent to K934795 (Card Guard Scientific Survival, Ltd., 1995) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.
- Decided
- May 4, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K963725 (1997). 6 ancestors in all, the oldest K934795 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 2 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 1 generation backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- This deviceK050853 PMP4 SpiroproCard Guard Scientific Survival, Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK072722 Meddorna Wireless PRN Spirometer 100Meddorna, LLC · 2008
- Descendant · cites it directly · 0 of its ownK060703 PMP4 BP Pro Blood Pressure MonitorCard Guard Scientific Survival, Ltd. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −2 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −1 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| 0 (this device) | K050853 | PMP4 Spiropro | Card Guard Scientific Survival, Ltd. | 2005 | — |
| +1 | K072722 | Meddorna Wireless PRN Spirometer 100 | Meddorna, LLC | 2008 | — |
| +1 | K060703 | PMP4 BP Pro Blood Pressure Monitor | Card Guard Scientific Survival, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 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 BZH? 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 BZH device
- #1 K252802 Peak Flow Meter (PF-10(BR-PEF231))score 13.5 · 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 |
|---|---|---|---|
| * | K934795 | Card GuardSummary page 2…s 4. Substantial Equivalence The substantially equivalence to the following predicate devices is claimed: Card Guard CG-303 , Spirophone K934795 Decision Date 04/14/1995 Card Guard SelfCheckTM ECG K042254 Decision… | 1995 |
| * | K042254 | PMP4 Selfcheck EcgSummary page 2…edicate devices is claimed: Card Guard CG-303 , Spirophone K934795 Decision Date 04/14/1995 Card Guard SelfCheckTM ECG K042254 Decision Date01/13/2005 The correlation between the comparable p… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K072722 (Meddorna, LLC, 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BZH devicesBZH Meter, Peak Flow, Spirometry: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZH
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZH
371in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZH
No recall names BZH since 2007.
Adverse event reports per year · BZH
1in 2015
MAUDE reports naming product code BZH, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 1 | — | 0 | 22 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 115 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 3 | 371 | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The PMP4 Spiro Pro is intended for pulmonary function testing for use in hospital, clinic or home settings. It allows patients to display and transmit their pulmonary function data via a communication device to medical professionals in a remote server.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050853: PMP4 Spiropro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050853
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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