510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Non Rebreathing Mask

K913164510(k) TraditionalCleared Jan 15, 1992182-day reviewClass I21 CFR 868.5570Recalls 6

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

Specialty Packaging Producs, Inc. · KGB Mask, Oxygen, Non-Rebreathing

Cleared on Jan 15, 1992 after a 182-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 6 times.

Decided
Jan 15, 1992
Review
182 days
Class
Class I
Product code
KGB
Recalls
6
Predicates
0

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

FIG. 1 — Lineage of K913164Source: 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.

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  • 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)

Recalls of this device

DateClassRecallRoot causeReason
Nov 11, 2020Class IIZ-0743-2021Process controlThere is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in…
Nov 11, 2020Class IIZ-0741-2021Process controlThere is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in…
Nov 11, 2020Class IIZ-0744-2021Process controlThere is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in…
Nov 11, 2020Class IIZ-0746-2021Process controlThere is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in…
Nov 11, 2020Class IIZ-0742-2021Process controlThere is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in…
Nov 11, 2020Class IIZ-0745-2021Process controlThere is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in…

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KGB devices

KGB Mask, Oxygen, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGB

FDA has decided no KGB device since 2007.

Median 510(k) review, days · KGB

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

Recalls per year · KGB

6in 2020

2020: 6
2007high 6 (2020) · low 0 (2007)2026

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

Adverse event reports per year · KGB

4in 2025

2008: 12009: 12010: 12011: 12012: 22013: 22014: 322015: 532016: 222017: 32018: 52019: 12020: 92022: 62023: 22024: 12025: 4
2007high 53 (2015) · low 0 (2007)2025

MAUDE reports naming product code KGB, 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—01
20100—01
20110—01
20120—02
20130—02
20140—032
20150—053
20160—022
20170—03
20180—05
20190—01
20200—69
20210—00
20220—06
20230—02
20240—01
20250—04
20260—0—

More from Specialty Packaging Producs, Inc.

11 FDA decisions under this applicant name. See the company

  • K922492Specialty Packaging Prod Bacterial/Viral FilterSpecialty Packaging Producs, Inc. · 1992
  • K913163Non Rebreathing ValveSpecialty Packaging Producs, Inc. · 1992
  • K913422Oxygen Tubing, 81503Specialty Packaging Producs, Inc. · 1992
  • K913216Trach T AdapterSpecialty Packaging Producs, Inc. · 1992
  • K913421Nasal Oxygen Cannula, 81585, 81587 & 81589Specialty Packaging Producs, Inc. · 1991

Recent decisions in KGB

The KGB category page

  • K970688Pocket RescueCheen Houng Ent. Co., Ltd. · 1997
  • K960401Ultimate SealHans Rudolph, Inc. · 1996
  • K941336Combo MaskGam Industries, Inc. · 1994
  • K935917Challenge Powder-Free, Hypoallergenic, Synthetic Surgical GlovesBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
  • K932347Compact MaskVital Signs, Inc. · 1994

https://510kreport.com/device/K913164 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913164: Non Rebreathing Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913164

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