510(k) Report

510(k) · Cleared

Cleared

Espree', Breathing Bag

K821309510(k) TraditionalCleared May 21, 198217-day reviewClass I21 CFR 868.5320

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

Esp Plastics, Inc. · BTC Bag, Reservoir

Cleared on May 21, 1982 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 21, 1982
Review
17 days
Class
Class I
Product code
BTC
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K821309Source: 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 BTC? 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 BTC devices

BTC Bag, Reservoir: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTC

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTC

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

Recalls per year · BTC

4in 2007

2007: 4
2007high 4 (2007) · low 0 (2008)2026

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

Adverse event reports per year · BTC

14in 2025

2007: 402010: 472011: 22013: 12017: 122018: 12019: 42020: 22021: 52022: 62023: 12024: 52025: 14
2007high 47 (2010) · low 0 (2008)2025

MAUDE reports naming product code BTC, 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—440
20080—00
20090—00
20100—047
20110—02
20120—00
20130—01
20140—00
20150—00
20160—00
20170—012
20181—01
20190—04
20200—02
20210—05
20220—06
20230—01
20240—05
20250—014
20260—0—

More from Esp Plastics, Inc.

4 FDA decisions under this applicant name. See the company

  • K821310Espree' Anesthesia Bacterial FilterEsp Plastics, Inc. · 1982
  • K821308Espree' Guedel Espree Berman AirwayEsp Plastics, Inc. · 1982
  • K821311Espree' Breathing Circuit (W/AccessEsp Plastics, Inc. · 1982

Recent decisions in BTC

The BTC category page

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  • K940220Rebreather BagsZefon Medical Products · 1994
  • K932584Breathing BagsMerit Medical Systems, Inc. · 1993
  • K932496Precision Med Products, LTD. Breathing BagsPrecision Med Products, Ltd. · 1993
  • K932581Breathing BagsMed-Plastics Intl., Inc. · 1993

https://510kreport.com/device/K821309 · printed Nov 6, 2026

Cite this page

510(k) Report. “K821309: Espree', Breathing Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K821309

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