510(k) Report

510(k) · Cleared

Cleared

Hannah Wireless Vital Signs Monitor

K991087510(k) TraditionalCleared Jan 12, 2000287-day reviewClass II21 CFR 868.2377

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ilife Systems, Inc. · FLS Monitor, Apnea, Facility Use

Cleared on Jan 12, 2000 as substantially equivalent to K844327 (Edentec Corp., 1985) and 6 other predicates after a 287-day review. Its family tree reaches back 1 generation to 1982.

Decided
Jan 12, 2000
Review
287 days
Class
Class II
Product code
FLS
Recalls
None
Predicates
7

Its longest line of descent runs back 1 generation to K822077 (1982). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor1988: 1 other ancestor1987: 1 other ancestor1985: 1 other ancestorK822077 · Respiration Monitor Type MR-10 · New Dimensions IN Medicine, Inc. · 198219801985199019952000
Other ancestors, by generation 1 generation back: 6 other ancestors K822077 · Respiration Monitor Type MR-10 · New Dimensions IN Medicine, Inc. · 19820
  1. Root · 1 generation backK822077 Respiration Monitor Type MR-10New Dimensions IN Medicine, Inc. · 1982
  2. This deviceK991087 Hannah Wireless Vital Signs MonitorIlife Systems, Inc. · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K822077Respiration Monitor Type MR-10New Dimensions IN Medicine, Inc.1982—
0 (this device)K991087Hannah Wireless Vital Signs MonitorIlife Systems, Inc.2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
198810
198910
199010
199710
FIG. 1 — Lineage of K991087, 1982–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 FLS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K844327Edentec Model 2000W Apnea Monitor
Summary page 1
…HANNAH system is an infant apnea monitor, which is substantially equivalent' to legally marketed devices, including the following: e EdenTec 2000W (applicant: EdenTec; K844327, K871302, K884614, K901060) e Monitron (applicant: American Health Products, Inc.; K874148) e Model AMI Infant Central Apnea/He…
Edentec Corp.1985—
*K871302Model 2000W Option H Configuration
Summary page 1
…ystem is an infant apnea monitor, which is substantially equivalent' to legally marketed devices, including the following: e EdenTec 2000W (applicant: EdenTec; K844327, K871302, K884614, K901060) e Monitron (applicant: American Health Products, Inc.; K874148) e Model AMI Infant Central Apnea/Heart Rate…
Edentec Corp.1987—
*K884614Edentec Model 2000W Option S Cardio-Resp. Process.
Summary page 1
…an infant apnea monitor, which is substantially equivalent' to legally marketed devices, including the following: e EdenTec 2000W (applicant: EdenTec; K844327, K871302, K884614, K901060) e Monitron (applicant: American Health Products, Inc.; K874148) e Model AMI Infant Central Apnea/Heart Rate Monitor (…
Edentec Corp.1989—
*K901060Edentec Model 2000W System 700 Monitor
Summary page 1
…apnea monitor, which is substantially equivalent' to legally marketed devices, including the following: e EdenTec 2000W (applicant: EdenTec; K844327, K871302, K884614, K901060) e Monitron (applicant: American Health Products, Inc.; K874148) e Model AMI Infant Central Apnea/Heart Rate Monitor (applicant…
Edentec Corp.1990—
*K874148Monitron System
Summary page 1
…keted devices, including the following: e EdenTec 2000W (applicant: EdenTec; K844327, K871302, K884614, K901060) e Monitron (applicant: American Health Products, Inc.; K874148) e Model AMI Infant Central Apnea/Heart Rate Monitor (applicant: Aequitron Medical, Inc.; K961972) ¢ Respiration Monitor Type M…
American Health Products, Inc.1988—
*K961972Model Ami Infant Central Aphea/Heart Rate Monitor
Summary page 1
…4614, K901060) e Monitron (applicant: American Health Products, Inc.; K874148) e Model AMI Infant Central Apnea/Heart Rate Monitor (applicant: Aequitron Medical, Inc.; K961972) ¢ Respiration Monitor Type MR-10 (applicant: New Dimensions In Medicine, Inc.; K822077) ' Any statement made in conjunction wi…
Aequitron Medical, Inc.1997—
*K822077Respiration Monitor Type MR-10
Summary page 1
…AMI Infant Central Apnea/Heart Rate Monitor (applicant: Aequitron Medical, Inc.; K961972) ¢ Respiration Monitor Type MR-10 (applicant: New Dimensions In Medicine, Inc.; K822077) ' Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other prod…
New Dimensions IN Medicine, Inc.1982—

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?

  • None of the 7 ancestors has a recall.

How does its category compare?

All FLS devices

FLS Monitor, Apnea, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLS

FDA has decided no FLS device since 2007.

Median 510(k) review, days · FLS

Too few FLS 510(k)s in any year since 2007 to give a median.

Recalls per year · FLS

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FLS

1in 2019

2007: 52008: 32009: 62010: 142011: 212012: 132013: 152014: 102015: 122016: 32018: 42019: 1
2007high 21 (2011) · low 0 (2017)2025

MAUDE reports naming product code FLS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—15
20080—03
20090—16
20100—014
20110—021
20120—013
20130—015
20140—010
20150—012
20160—03
20170—00
20180—04
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The HANNAH Wireless Vital Signs Monitor is indicated for the continuous monitoring of an infant’s heart rate, respiration rate, and occurrences of central apnea in home, hospital and other environments.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Recent decisions in FLS

The FLS category page

  • K011597Smartmonitor 2, Model 4000Respironics Georgia, Inc. · 20022 recalls
  • K962865Rembrandt SystemAirsep Corp. · 1996
  • K951246Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography OptionsProtocol Systems, Inc. · 1996
  • K894973Respitrace PlusHogan & Hartson · 1989
  • K832999Respiration MonitorLitton Medical Electronics · 1984

https://510kreport.com/device/K991087 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991087: Hannah Wireless Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991087

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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