510(k) · Cleared
ClearedSandman Pocket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eb Neuro S.P.A. · MNR Ventilatory Effort Recorder
Cleared on Oct 3, 2006 as substantially equivalent to K990565 (Nellcor Puritan Bennett, Inc., 1999) and 1 other predicate after an 81-day review. Its family tree reaches back 4 generations to 1997. 7 later devices descend from it.
- Decided
- Oct 3, 2006
- Review
- 81 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K962603 (1997). 11 ancestors in all, the oldest K930790 (1994). 7 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 1 generation backK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- This deviceK061996 Sandman PocketEb Neuro S.P.A. · 2006
- Descendant · cites it directly · 4 of its ownK093728 BE Micro, TreaEb Neuro S.P.A. · 2010
- Descendant · 2 generations on · 3 of its ownK133355 Cadwell Flex Eeg/PSGCadwell Industries, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK180269 Cadwell Apollo SystemCadwell Industries, Inc. · 2018
- Descendant · 4 generations on · 1 of its ownK201819 Cadwell Apollo SystemCadwell Industries, Inc. · 2020
- Descendant · 5 generations on · 0 of its ownK221959 Q21Neurofield, Inc. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K093728BE Micro, TreaEb Neuro S.P.A. · 2010 · cites it directly4descendants
- K133355Cadwell Flex Eeg/PSGCadwell Industries, Inc. · 2014 · 2 generations on3descendants
- K180269Cadwell Apollo SystemCadwell Industries, Inc. · 2018 · 3 generations on2descendants
- K201819Cadwell Apollo SystemCadwell Industries, Inc. · 2020 · 4 generations on1descendant
- K221959Q21Neurofield, Inc. · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −1 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| 0 (this device) | K061996 | Sandman Pocket | Eb Neuro S.P.A. | 2006 | — |
| +1 | K093728 | BE Micro, Trea | Eb Neuro S.P.A. | 2010 | — |
| +2 | K133355 | Cadwell Flex Eeg/PSG | Cadwell Industries, Inc. | 2014 | — |
| +3 | K180269 | Cadwell Apollo System | Cadwell Industries, Inc. | 2018 | — |
| +4 | K201819 | Cadwell Apollo System | Cadwell Industries, Inc. | 2020 | — |
| +5 | K221959 | Q21 | Neurofield, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 MNR? 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 MNR device
- #1 K244027 Sansa Hsatscore 18.1 · 12 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 |
|---|---|---|---|
| * | K990565 | SuzanneSummary page 1…Number: MNR 807.92(a)(3) Predicate Device(s) Nellcor Puritan Bennett Inc. SUZANNE K990565 Respironics, IN Alice 5 K040595 Additional Substantial Equivalence Information is p… | 1999 |
| * | K040595 | ALICE 5Summary page 1…Predicate Device(s) Nellcor Puritan Bennett Inc. SUZANNE K990565 Respironics, IN Alice 5 K040595 Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table.… | 2004 |
What descends from it? (7)
3 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 9 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K093728 (Eb Neuro S.P.A., 2010) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K990565.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNR
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNR
165in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNR
43in 2025
MAUDE reports naming product code MNR, 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 | 6 | 124 | 2 | 1 |
| 2008 | 14 | 118 | 0 | 0 |
| 2009 | 8 | 89 | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 9 | 90 | 1 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 161 | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 4 | 229 | 0 | 4 |
| 2016 | 3 | 281 | 0 | 10 |
| 2017 | 4 | 275 | 0 | 4 |
| 2018 | 3 | 147 | 0 | 2 |
| 2019 | 8 | 383 | 0 | 3 |
| 2020 | 5 | 192 | 0 | 5 |
| 2021 | 3 | 137 | 1 | 5 |
| 2022 | 7 | 266 | 0 | 4 |
| 2023 | 6 | 183 | 0 | 13 |
| 2024 | 6 | 217 | 0 | 11 |
| 2025 | 10 | 165 | 0 | 43 |
| 2026 | 5 | 227 | 1 | — |
What is it indicated for?
Intended for use in collecting and recording physiological data to be used in
polysomnography and sleep disorder studies. The Sandman Pocket is indended for
pediatric through adult patient populations, and can be used in either home or hospital
environments.
The Sandman Pocket is not intended for use as life supporting equipment, such as a
vital sign monitoring in on intensive care unit. The device does not produce alarms and
is not intended as an automated apnea monitor.
The Sandman Pocket is only to be used under the direction or supervision of a
physician, technologist or clinician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061996: Sandman Pocket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061996
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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