510(k) Report

510(k) · Cleared

Cleared

Beehive-64 or Beehive-32, Digital Eeg Recording

K884937510(k) TraditionalCleared Apr 14, 1989137-day reviewClass I21 CFR 872.6475

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

Grass-Telefactor Product Group · EEG Heat Source For Bleaching Teeth

Cleared on Apr 14, 1989 after a 137-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.

Decided
Apr 14, 1989
Review
137 days
Class
Class I
Product code
EEG
Recalls
None
Predicates
0

12 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1998: 2 descendants cleared2004: 1 descendant cleared1999: 1 descendant cleared2005: 1 descendant cleared2000: 1 descendant cleared2008: 1 descendant cleared2018: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK884937 Beehive-64 or Beehive-32, Digital Eeg RecordingGrass-Telefactor Product Group · 1989
  2. Descendant · cites it directly · 11 of its ownK972202 Deeg-LiteGrass-Telefactor Product Group · 1997
  3. Descendant · 2 generations on · 9 of its ownK974587 H2OGrass-Telefactor Product Group · 1998
  4. Descendant · 3 generations on · 8 of its ownK992291 H20- Tethered OptionGrass-Telefactor Product Group · 1999
  5. Descendant · 3 generations on · 6 of its ownK033978 ADAMAstro-Med, Inc. · 2004
  6. Descendant · 4 generations on · 6 of its ownK994142 Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

1997: 11998: 21999: 12000: 12004: 12005: 12008: 12013: 12015: 12018: 12022: 1
1997high 2 (1998) · low 0 (2001)2026

Most influential descendants

Showing 5 of 12 · See all
  • K972202Deeg-LiteGrass-Telefactor Product Group · 1997 · cites it directly11descendants
  • K974587H2OGrass-Telefactor Product Group · 1998 · 2 generations on9descendants
  • K992291H20- Tethered OptionGrass-Telefactor Product Group · 1999 · 3 generations on8descendants
  • K033978ADAMAstro-Med, Inc. · 2004 · 3 generations on6descendants
  • K994142Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K884937Beehive-64 or Beehive-32, Digital Eeg RecordingGrass-Telefactor Product Group1989—
+1K972202Deeg-LiteGrass-Telefactor Product Group1997—
+2K974587H2OGrass-Telefactor Product Group1998—
+3K992291H20- Tethered OptionGrass-Telefactor Product Group1999—
+3K033978ADAMAstro-Med, Inc.2004—
+4K994142Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co.2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
199910
200010
200410
200510
200810
201310
201510
201810
202210
FIG. 1 — Lineage of K884937, 1989–2022Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EEG? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (12)

See all 12

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972202Deeg-LiteGrass-Telefactor Product Group199711

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, K972202 (Grass-Telefactor Product Group, 1997) has gone furthest, with 11 descendants of its own.

How does its category compare?

All EEG devices

EEG Heat Source For Bleaching Teeth: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EEG

2in 2012

2007: 12012: 2
2007high 2 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EEG

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

Recalls per year · EEG

No recall names EEG since 2007.

Adverse event reports per year · EEG

7in 2025

2007: 32008: 32010: 32011: 72012: 22013: 22014: 72015: 12016: 82017: 102018: 62019: 32020: 62021: 62022: 42024: 12025: 7
2007high 10 (2017) · low 0 (2009)2025

MAUDE reports naming product code EEG, 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
20071—03
20080—03
20090—00
20100—03
20110—07
20122—02
20130—02
20140—07
20150—01
20160—08
20170—010
20180—06
20190—03
20200—06
20210—06
20220—04
20230—00
20240—01
20250—07
20260—0—
Cite this page

510(k) Report. “K884937: Beehive-64 or Beehive-32, Digital Eeg Recording.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884937

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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