510(k) · Cleared
ClearedHealthdyne's Apnea/Heart Monitor, Model 900S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthdyne, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on May 23, 1989 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 23, 1989
- Review
- 56 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK892006 Healthdyne's Apnea/Heart Monitor, Model 900SHealthdyne, Inc. · 1989
- Descendant · cites it directly · 2 of its ownK011597 Smartmonitor 2, Model 4000Respironics Georgia, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 1 of its ownK032403 Smartmonitor 2 Professional Series (PS)Respironics, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 0 of its ownK061256 Smartmonitor 2PSRespironics, Inc. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK982550 Browser (Event Software) Model # 4500ERespironics, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K011597Smartmonitor 2, Model 4000Respironics Georgia, Inc. · 2002 · cites it directly2descendants
- K032403Smartmonitor 2 Professional Series (PS)Respironics, Inc. · 2003 · 2 generations on1descendant
- K061256Smartmonitor 2PSRespironics, Inc. · 2006 · 3 generations on0descendants
- K982550Browser (Event Software) Model # 4500ERespironics, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K892006 | Healthdyne's Apnea/Heart Monitor, Model 900S | Healthdyne, Inc. | 1989 | — |
| +1 | K011597 | Smartmonitor 2, Model 4000 | Respironics Georgia, Inc. | 2002 | 2 |
| +2 | K032403 | Smartmonitor 2 Professional Series (PS) | Respironics, Inc. | 2003 | 1 |
| +3 | K061256 | Smartmonitor 2PS | Respironics, Inc. | 2006 | 3 |
| +1 | K982550 | Browser (Event Software) Model # 4500E | Respironics, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRT? 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 DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K011597 (Respironics Georgia, Inc., 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, 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 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
https://510kreport.com/device/K892006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K892006: Healthdyne's Apnea/Heart Monitor, Model 900S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K892006
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026