510(k) Report

510(k) · Cleared

Cleared

Safe-T-Shield Mouthpiece

K865093510(k) TraditionalCleared Jan 15, 198716-day reviewClass I21 CFR 868.5620

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

Medi Nuclear Corp., Inc. · BYP Mouthpiece, Breathing

Cleared on Jan 15, 1987 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 15, 1987
Review
16 days
Class
Class I
Product code
BYP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K865093Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 BYP? 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
Get a 510(k) Report

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 BYP devices

BYP Mouthpiece, Breathing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BYP

FDA has decided no BYP device since 2007.

Median 510(k) review, days · BYP

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

Recalls per year · BYP

No recall names BYP since 2007.

Adverse event reports per year · BYP

1in 2025

2010: 22015: 12016: 22019: 12023: 12025: 1
2007high 2 (2010) · low 0 (2007)2025

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

More from Medi Nuclear Corp., Inc.

9 FDA decisions under this applicant name. See the company

  • K082541Healthline Medicator / Redineb Aerosol Drug Delivery SystemMedi Nuclear Corp., Inc. · 2008
  • K080969Healthline Redi-Neb Medication Nebulizer, Model RN-510Medi Nuclear Corp., Inc. · 2008
  • K080657Neb-90 Large Volume Medication NebulizerMedi Nuclear Corp., Inc. · 2008
  • K915075Nebulizer (Direct Patient Interface)Medi Nuclear Corp., Inc. · 1992
  • K865107Aero-Vent Aerosol UnitMedi Nuclear Corp., Inc. · 1987

Recent decisions in BYP

The BYP category page

  • K955657North State Plastics Respiratory MouthpieceNorth State Plastics, Inc. · 1996
  • K944512Truzone PFM Disposable MouthpieceMonaghan Medical Corp. · 1994
  • K893791Breathing MouthpieceDiemolding Corp. · 1989
  • K872037AerochamberMonaghan Medical Corp. · 1987
  • K863049Inhalation AidBoehringer Ingelheim Pharmaceuticals, Inc. · 1986

https://510kreport.com/device/K865093 · printed Nov 4, 2026

Cite this page

510(k) Report. “K865093: Safe-T-Shield Mouthpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K865093

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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