510(k) Report

510(k) · Cleared

Cleared

Headstrap

K854537510(k) TraditionalCleared Dec 3, 198520-day reviewClass I21 CFR 868.5560

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

Life Design Systems, Inc. · BTK Strap, Head, Gas Mask

Cleared on Dec 3, 1985 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 3, 1985
Review
20 days
Class
Class I
Product code
BTK
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K854537Source: FDA 510(k) database · 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 BTK? 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?

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.

How does its category compare?

All BTK devices

BTK Strap, Head, Gas Mask: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTK

FDA has decided no BTK device since 2007.

Median 510(k) review, days · BTK

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

Recalls per year · BTK

No recall names BTK since 2007.

Adverse event reports per year · BTK

1in 2021

2008: 12012: 112013: 12014: 12016: 22017: 22019: 12020: 22021: 1
2007high 11 (2012) · low 0 (2007)2025

MAUDE reports naming product code BTK, 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—00
20080—01
20090—00
20100—00
20110—00
20120—011
20130—01
20140—01
20150—00
20160—02
20170—02
20180—00
20190—01
20200—02
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Life Design Systems, Inc.

29 FDA decisions under this applicant name. See the company

  • K913714Modification Manual Pulmon Resuscitor/Pulmanex (TM)Life Design Systems, Inc. · 1992
  • K885313Humidi-Flex TMLife Design Systems, Inc. · 1989
  • K893030Child Size - Filter Flex (TM)Life Design Systems, Inc. · 1989
  • K892862Flex-Cup PercussorLife Design Systems, Inc. · 1989
  • K892221Pulmonary Resuscitator, ModificationLife Design Systems, Inc. · 1989

Recent decisions in BTK

The BTK category page

  • K944949General Anesthesia SystemVital Signs, Inc. · 19941 recall
  • K914335Strap, Head, Gas MaskVital Signs, Inc. · 1992
  • K853573Medipart Face Mask Headstrap MP-9100Medipart Jerry Alexander · 1985
  • K831008Head StrapMedovations, Inc. · 1983
  • K810991HeadstrapRespironics, Inc. · 1981

https://510kreport.com/device/K854537 · printed Nov 5, 2026

Cite this page

510(k) Report. “K854537: Headstrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K854537

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026