Hill Laboratories Co.: FDA filings under this applicant name

FDA lists 17 510(k) clearances under the applicant name “Hill Laboratories Co.” (first 1993, latest 2010), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 206 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

YearClearancesMedian review days
20120—
20130—
20140—
20150—
20160—
20170—
20180—
20190—
20200—
20210—
20220—
20230—
20240—
20250—
20260—

Top product codes

Product codeDeviceSubmissions510(k) clearances
INQTable, Powered1010
ILYLamp, Infrared, Therapeutic Heating22
JFBTable, Physical Therapy, Multi Function22
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat11
ITHEquipment, Traction, Powered11
PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat11

Review panels

Most recent Hill Laboratories Co. 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K090250ELECTRO-LIGHT THERAPYILY2010-02-11374
K083183AKLARUS PHOTOTHERAPY SYSTEMILY2009-07-16261
K072256HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODELPFW2008-03-12212
K062256HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEMIMI2007-02-26206
K063034AIR-FLEX WITH AUTO-DISTRACTIONJFB2006-12-1472
K043239HEALTHSTAR ELITEITH2004-12-2229
K952357THE HILL ADJUSTABLE PODIATRY MODELINQ1995-07-0670
K952359THE HILL ADJUSTABLE HA90CINQ1995-06-2256
K952358THE HILL ADJUSTABLE P.T. MOBILIZATION TABLEINQ1995-06-2256
K952356THE HILL ADJUSTABLE COUNTERSTRAIN TABLEINQ1995-06-2252

7 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Hill Laboratories Co..

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

Frequently asked questions

How many FDA 510(k) clearances are listed under Hill Laboratories Co.?

FDA lists 17 510(k) clearances under the applicant name “Hill Laboratories Co.” (first 1993, latest 2010), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Hill Laboratories Co.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Hill Laboratories Co. is 206 days.

Which FDA product codes appear under Hill Laboratories Co.?

The most frequent FDA product codes under this applicant name are INQ (Table, Powered, 10); ILY (Lamp, Infrared, Therapeutic Heating, 2); JFB (Table, Physical Therapy, Multi Function, 2).

Next steps

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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