510(k) · Cleared

Cleared

Autocuff (Photos Enclosed with 510K

K822286510(k) TraditionalCleared Aug 27, 198228-day reviewClass I21 CFR 880.5420

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

Partamed, Inc. · KZD Infusor, Pressure, For I.V. Bags

Cleared on Aug 27, 1982 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided: Aug 27, 1982
Review: 28 days
Class: Class I
Product code: KZD
Recalls: None
Predicates: 0

6 later devices descend from it, 3 citing it directly.

This deviceK822286 Autocuff (Photos Enclosed with 510KPartamed, Inc. · 1982
Descendant · cites it directly · 5 of its ownK973133 Big Bag 3000 Pressure InfusorByron Medical · 1997
Descendant · 2 generations on · 2 of its ownK980738 Psi-Tec Syringe Infusion Pump and Accessories for General Fluid…Byron Medical · 1998
Descendant · 3 generations on · 1 of its ownK153599 Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC · 2016
Descendant · cites it directly · 1 of its ownK980089 3600 Presure Infusor, Sigmacon 3600, Lapro Flow 3000Valley West, Inc. · 1998
Descendant · 4 generations on · 0 of its ownK230083 SafiraMedovate Limited · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1997high 2 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 6 · See all

K973133Big Bag 3000 Pressure InfusorByron Medical · 1997 · cites it directly5descendants
K980738Psi-Tec Syringe Infusion Pump and Accessories for General Fluid Irrigaion/InfiltrationByron Medical · 1998 · 2 generations on2descendants
K153599Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC · 2016 · 3 generations on1descendant
K9800893600 Presure Infusor, Sigmacon 3600, Lapro Flow 3000Valley West, Inc. · 1998 · cites it directly1descendant
K230083SafiraMedovate Limited · 2023 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K822286	Autocuff (Photos Enclosed with 510K	Partamed, Inc.	1982	—
+1	K973133	Big Bag 3000 Pressure Infusor	Byron Medical	1997	—
+2	K980738	Psi-Tec Syringe Infusion Pump and Accessories for General Fluid…	Byron Medical	1998	—
+3	K153599	Concert Medical Hands-Free Syringe (HFS)	Concert Medical, LLC	2016	—
+1	K980089	3600 Presure Infusor, Sigmacon 3600, Lapro Flow 3000	Valley West, Inc.	1998	—
+4	K230083	Safira	Medovate Limited	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	2	0
1999	1	0
2016	1	0
2023	1	0

FIG. 1 — Lineage of K822286, 1982–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 KZD? 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? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K973133	Big Bag 3000 Pressure Infusor	Byron Medical	1997	5
K980089	3600 Presure Infusor, Sigmacon 3600, Lapro Flow 3000	Valley West, Inc.	1998	1
K990447	1000 Pressure Infusion Sigmacon 1000	Valley West, Inc.	1999	0

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, K973133 (Byron Medical, 1997) has gone furthest, with 5 descendants of its own.

How does its category compare?

All KZD devices

KZD Infusor, Pressure, For I.V. Bags: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KZD

FDA has decided no KZD device since 2007.

Median 510(k) review, days · KZD

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

Recalls per year · KZD

1in 2011

2007high 11 (2008) · low 0 (2007)2026

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

Adverse event reports per year · KZD

41in 2025

2007high 72 (2014) · low 0 (2007)2025

MAUDE reports naming product code KZD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	11	3
2009	—	1	6
2010	—	0	9
2011	—	1	12
2012	—	0	1
2013	—	0	0
2014	—	0	72
2015	—	0	31
2016	—	0	4
2017	—	0	38
2018	—	0	6
2019	—	0	4
2020	—	0	8
2021	—	0	13
2022	—	0	45
2023	—	0	31
2024	—	0	43
2025	—	0	41
2026	—	0	—

https://510kreport.com/device/K822286 · printed Nov 6, 2026

Cite this page

510(k) Report. “K822286: Autocuff (Photos Enclosed with 510K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822286

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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