510(k) · Cleared
ClearedBrowser (Event Software) Model # 4500E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · BZQ Monitor, Breathing Frequency
Cleared on Oct 5, 1998 as substantially equivalent to K892006 (Healthdyne, Inc., 1989) after a 75-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Oct 5, 1998
- Review
- 75 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K892006 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK892006 Healthdyne's Apnea/Heart Monitor, Model 900SHealthdyne, Inc. · 1989
- This deviceK982550 Browser (Event Software) Model # 4500ERespironics, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892006 | Healthdyne's Apnea/Heart Monitor, Model 900S | Healthdyne, Inc. | 1989 | — |
| 0 (this device) | K982550 | Browser (Event Software) Model # 4500E | Respironics, Inc. | 1998 | — |
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 BZQ? 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 BZQ device
- #1 K251326 Respiration Rate algorithmscore 20.2 · 30 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K892006 | Healthdyne's Apnea/Heart Monitor, Model 900SSummary page 1…: Breathing Frequency Monitor, 21 CFR 868.2375 Device Classification: Class Il Predicate Devices: Healthdyne Technologies, Inc. 9500E software. Originally cleared under K892006 (5/23/89), and a subsequent modification KS03287 (8/17/90). Device Description: Browser is a Windows 95 software program used fo… | 1989 |
| Kept off the family tree | K903287 | FDA’s K903287 is Model 900S Apnea/Heart Monitor Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1990 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K892006.
How does its category compare?
All BZQ devicesBZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZQ
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZQ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZQ
2in 2022
MAUDE reports naming product code BZQ, 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 | 2 | — | 0 | 7 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 121 | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 3 | 261 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 3 | 198 | 0 | 10 |
| 2019 | 1 | — | 0 | 13 |
| 2020 | 2 | — | 0 | 10 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 198 | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 7 | 255 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Browser is a software program that is used by a HCP (Healthcare Professional) to view, analyze, and edit patient data gathered with a SmartMonitor® Infant Apnea Monitor.
Information that is collected includes patient information, equipment parameters, compliance logs, patient events, equipment events, and waveforms.
The data is downloaded to a PC, either by direct connection to the monitor or by modem. The data can also be retrieved from a computer file or memory disk such as a floppy or card.
The software allows the user to review and manipulate event information, produce reports, save changes, and forward data via e-mail.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982550 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982550: Browser (Event Software) Model # 4500E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982550
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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