510(k) · Cleared
ClearedQuanta Pulse Oximeter, Model: Pulse Link 1000 or QH100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quanta Computer, Inc. · DQA Oximeter
Cleared on Mar 5, 2009 as substantially equivalent to K050056 (Nonin Medical, Inc., 2005) and 1 other predicate after a 140-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Mar 5, 2009
- Review
- 140 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K962603 (1997). 16 ancestors in all, the oldest K904039 (1990). No later device cites it as a predicate yet.
- Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 3 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 2 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 1 generation backK051352 Oximax NPB-40 Handheld Pulse OximeterNellcor Puritan Bennett, Inc. · 2005
- This deviceK083079 Quanta Pulse Oximeter, Model: Pulse Link 1000 or QH100Quanta Computer, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −4 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −3 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −2 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −1 | K051352 | Oximax NPB-40 Handheld Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2005 | — |
| 0 (this device) | K083079 | Quanta Pulse Oximeter, Model: Pulse Link 1000 or QH100 | Quanta Computer, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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 |
|---|---|---|---|
| * | K050056 | Model 2500A Palmsat Pulse OximeterSummary page 2…ct Code: DQA Regulation Number: 21CFR 870.2700 4. Predicate Device: * Palmsat Pulse Oximeter, Model #2500A (K#050056) marketed by NONIN MEDICAL, INC.. * OXIMAX Pulse Oximeter, Model #NPB-40… | 2005 |
| * | K051352 | Oximax NPB-40 Handheld Pulse OximeterSummary page 2…(K#050056) marketed by NONIN MEDICAL, INC.. * OXIMAX Pulse Oximeter, Model #NPB-40 (K#051352)marketed by NELLCOR PURITAN BENNETT, INC. 5. Intended Use: The Quanta Pulse Oximeter, Mode… | 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 12 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 5 of the 16 ancestors have a recall of any class.
- 7 other devices also cite its predicate K050056.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The Quanta Pulse Oximeter, Model no. Pulse Link 1000 (or QH 100) is a handheld
pulse oximeter with alarm. It is intended to be used by trained healthcare
professionals in hospital, hospital type facilities, as well as in the home care
environment.
The Pulse Link 1000 Pulse Oximeter is indicated for non-invasive continuous
monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse
rate of patients on fingers (forefinger or middle finger).
The Pulse Link 1000 Pulse Oximeter is re-useable. It is indicated for adult patients
under no-motion conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083079 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083079: Quanta Pulse Oximeter, Model: Pulse Link 1000 or QH100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083079
Report an extraction error
Are you the manufacturer?
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